Trial Outcomes & Findings for Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma (NCT NCT01832727)
NCT ID: NCT01832727
Last Updated: 2020-07-13
Results Overview
Toxicities (graded per the Common Terminology Criteria for Adverse Events v 4.03) were considered DLTs if judged by the investigator to be related to oprozomib and occurred in the first 14 days of treatment, with treatment at the dose to be studied (i.e., Cycle 1 for continuous dosing or Cycle 2 for step-up dosing). A DLT was categorized as nonhematologic or hematologic. Examples include: * Any ≥ Grade 3 nonhematologic AE, with exceptions or qualifications such as Grade 3 nausea, vomiting, diarrhea, or constipation were considered a DLT only if lasting for \> 7 days despite optimal supportive care * Grade 3 fatigue lasting \> 14 days * Grade 4 neutropenia: absolute neutrophil count (ANC) \< 500 cells/mcL lasting ≥ 7 days * Febrile neutropenia: Any single temperature ≥ 38.3°C or a sustained temperature of ≥ 38.0°C for over 1 hour with ≥ Grade 3 neutropenia (ANC \< 1000 cells/mcL) * Grade 3/4 thrombocytopenia * Others specified in the protocol
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Day 1 to Day 14 (Cycle 1) for continous dosing and Day 15 to Day 28 (Cycle 2) for step-up dosing
Results posted on
2020-07-13
Participant Flow
This study was conducted at 18 centers in the United States and France.
Eighty-one subjects were screened; sixteen were not enrolled due to entry criteria violations.
Participant milestones
| Measure |
Cohort 180 mg 5/14 Schedule (Phase 1b)
Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 210 mg 5/14 Schedule (Phase 1b)
Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.
|
Cohort 150/180 mg 5/14 Schedule (Phase 1b)
Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward. Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 210 mg 2/7 Schedule (Phase 1b)
Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.
|
Cohort 240 mg 2/7 Schedule (Phase 1b)
Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 270 mg 2/7 Schedule (Phase 1b)
Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 300 mg 2/7 Schedule (Phase 1b)
Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 330 mg 2/7 Schedule (Phase 1b)
Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
3
|
4
|
4
|
6
|
8
|
6
|
18
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
3
|
4
|
4
|
6
|
8
|
6
|
18
|
Reasons for withdrawal
| Measure |
Cohort 180 mg 5/14 Schedule (Phase 1b)
Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 210 mg 5/14 Schedule (Phase 1b)
Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.
|
Cohort 150/180 mg 5/14 Schedule (Phase 1b)
Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward. Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 210 mg 2/7 Schedule (Phase 1b)
Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.
|
Cohort 240 mg 2/7 Schedule (Phase 1b)
Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 270 mg 2/7 Schedule (Phase 1b)
Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 300 mg 2/7 Schedule (Phase 1b)
Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 330 mg 2/7 Schedule (Phase 1b)
Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
6
|
1
|
0
|
1
|
1
|
2
|
1
|
9
|
|
Overall Study
Disease progression
|
3
|
0
|
2
|
1
|
3
|
3
|
6
|
2
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
1
|
0
|
1
|
0
|
2
|
1
|
|
Overall Study
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Cohort 180 mg 5/14 Schedule (Phase 1b)
n=9 Participants
Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 210 mg 5/14 Schedule (Phase 1b)
n=7 Participants
Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule). Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.
|
Cohort 150/180 mg 5/14 Schedule (Phase 1b)
n=3 Participants
Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward. Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 210 mg 2/7 Schedule (Phase 1b)
n=4 Participants
Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.
|
Cohort 240 mg 2/7 Schedule (Phase 1b)
n=4 Participants
Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 270 mg 2/7 Schedule (Phase 1b)
n=6 Participants
Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 300 mg 2/7 Schedule (Phase 1b)
n=8 Participants
Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 330 mg 2/7 Schedule (Phase 1b)
n=6 Participants
Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Phase 2 300 mg 2/7 Schedule
n=18 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
33 Participants
n=42 Participants
|
|
Age, Customized
65 - <75 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
|
Age, Customized
>=75 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
38 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
55 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
47 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 14 (Cycle 1) for continous dosing and Day 15 to Day 28 (Cycle 2) for step-up dosingPopulation: Safety population
Toxicities (graded per the Common Terminology Criteria for Adverse Events v 4.03) were considered DLTs if judged by the investigator to be related to oprozomib and occurred in the first 14 days of treatment, with treatment at the dose to be studied (i.e., Cycle 1 for continuous dosing or Cycle 2 for step-up dosing). A DLT was categorized as nonhematologic or hematologic. Examples include: * Any ≥ Grade 3 nonhematologic AE, with exceptions or qualifications such as Grade 3 nausea, vomiting, diarrhea, or constipation were considered a DLT only if lasting for \> 7 days despite optimal supportive care * Grade 3 fatigue lasting \> 14 days * Grade 4 neutropenia: absolute neutrophil count (ANC) \< 500 cells/mcL lasting ≥ 7 days * Febrile neutropenia: Any single temperature ≥ 38.3°C or a sustained temperature of ≥ 38.0°C for over 1 hour with ≥ Grade 3 neutropenia (ANC \< 1000 cells/mcL) * Grade 3/4 thrombocytopenia * Others specified in the protocol
Outcome measures
| Measure |
Phase 2 300 mg 2/7 Schedule
n=9 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
210 mg Oprozomib Tablet
n=7 Participants
Participants who were administered 210 mg oprozomib tablets.
|
240 mg Oprozomib Tablet
n=3 Participants
Participants who were administered 240 mg oprozomib tablets.
|
270 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 270 mg oprozomib tablets.
|
300 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 300 mg oprozomib tablets.
|
150 mg Oprozomib ER Tablet
n=6 Participants
Participants who were administered 150 mg extended release oprozomib tablets.
|
300 mg Oprozomib ER Tablet
n=8 Participants
Participants who were administered 300 mg extended release oprozomib tablets.
|
330 mg Oprozomib ER Tablet
n=6 Participants
Participants who were administered 330 mg extended release oprozomib tablets.
|
Phase 2 300 mg 2/7 Schedule
n=18 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants With Dose-Limiting Toxicities (DLT)
Participants reporting >=1 DLT
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Participants With Dose-Limiting Toxicities (DLT)
Mental status changes
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Dose-Limiting Toxicities (DLT)
Alanine aminotransferase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Dose-Limiting Toxicities (DLT)
Aspartate aminotransferase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Dose-Limiting Toxicities (DLT)
Hypertension
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Dose-Limiting Toxicities (DLT)
Subarachnoid haemorrhage
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Dose-Limiting Toxicities (DLT)
Thrombocytopenia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Dose-Limiting Toxicities (DLT)
Anemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Participants With Dose-Limiting Toxicities (DLT)
Nausea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Participants With Dose-Limiting Toxicities (DLT)
Upper respiratory tract infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Participants With Dose-Limiting Toxicities (DLT)
Vomiting
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Participants With Dose-Limiting Toxicities (DLT)
Pain in jaw
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Week 282Population: Safety population
AE defined as any untoward medical occurrence in a clinical trial participant. Treatment-emergent adverse events were defined as adverse events that start on or after the first day of study treatment and within 30 days of the last day of study treatment. An adverse event that was present before the first administration of study treatment and subsequently worsens in severity during treatment was also considered to be treatment-emergent. Serious AE defined as AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other significant medical hazard. Severity of AEs assessed according to Common Terminology Criteria for Adverse Events (CTCAE, v4.03) based on the general guideline: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to AE. IP=investigational product
Outcome measures
| Measure |
Phase 2 300 mg 2/7 Schedule
n=9 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
210 mg Oprozomib Tablet
n=7 Participants
Participants who were administered 210 mg oprozomib tablets.
|
240 mg Oprozomib Tablet
n=3 Participants
Participants who were administered 240 mg oprozomib tablets.
|
270 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 270 mg oprozomib tablets.
|
300 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 300 mg oprozomib tablets.
|
150 mg Oprozomib ER Tablet
n=6 Participants
Participants who were administered 150 mg extended release oprozomib tablets.
|
300 mg Oprozomib ER Tablet
n=8 Participants
Participants who were administered 300 mg extended release oprozomib tablets.
|
330 mg Oprozomib ER Tablet
n=6 Participants
Participants who were administered 330 mg extended release oprozomib tablets.
|
Phase 2 300 mg 2/7 Schedule
n=18 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants With Treatment-Emergent Adverse Events (TEAEs) During Phase 1b and 2
>=1 TEAE
|
9 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
18 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs) During Phase 1b and 2
Grade >=3 (severe)
|
8 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
16 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs) During Phase 1b and 2
Serious AE
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
9 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs) During Phase 1b and 2
Leading to discontinuation of IP
|
4 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
11 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs) During Phase 1b and 2
Fatal AE
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Week 282Population: Safety population
AE defined as any untoward medical occurrence in a clinical trial participant. TEAEs were defined as AEs that start on or after the first day of study treatment and within 30 days of the last day of study treatment. An AE that was present before the first administration of study treatment and subsequently worsens in severity during treatment was also considered a TEAE. Investigator assessed AEs for relatedness to study drug. Serious AE defined as AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other significant medical hazard. Severity of AEs assessed according to Common Terminology Criteria for Adverse Events (CTCAE, v4.03) based on the general guideline: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to AE. IP=investigational product
Outcome measures
| Measure |
Phase 2 300 mg 2/7 Schedule
n=9 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
210 mg Oprozomib Tablet
n=7 Participants
Participants who were administered 210 mg oprozomib tablets.
|
240 mg Oprozomib Tablet
n=3 Participants
Participants who were administered 240 mg oprozomib tablets.
|
270 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 270 mg oprozomib tablets.
|
300 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 300 mg oprozomib tablets.
|
150 mg Oprozomib ER Tablet
n=6 Participants
Participants who were administered 150 mg extended release oprozomib tablets.
|
300 mg Oprozomib ER Tablet
n=8 Participants
Participants who were administered 300 mg extended release oprozomib tablets.
|
330 mg Oprozomib ER Tablet
n=6 Participants
Participants who were administered 330 mg extended release oprozomib tablets.
|
Phase 2 300 mg 2/7 Schedule
n=18 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Participants With Treatment-Related, Treatment-Emergent Adverse Events (TEAEs) During Phase 1b and 2
>=1 related TEAE
|
9 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
18 Participants
|
|
Participants With Treatment-Related, Treatment-Emergent Adverse Events (TEAEs) During Phase 1b and 2
Grade >=3 (severe)
|
8 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
14 Participants
|
|
Participants With Treatment-Related, Treatment-Emergent Adverse Events (TEAEs) During Phase 1b and 2
Serious AE
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Participants With Treatment-Related, Treatment-Emergent Adverse Events (TEAEs) During Phase 1b and 2
Leading to discontinuation of IP
|
3 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
|
Participants With Treatment-Related, Treatment-Emergent Adverse Events (TEAEs) During Phase 1b and 2
Fatal AE
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Screening: Day 14 to Day -1; During study: Day 1 up to 13.16 monthsPopulation: Safety Population
Disease response and progression were determined using the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC), except for minimal response (MR) and near complete response (nCR) which was based on the European Group for Blood and Marrow Transplantation (EBMT) criteria. Evaluations reported were assessed by the investigator for participants in Phase 2.
Outcome measures
| Measure |
Phase 2 300 mg 2/7 Schedule
n=18 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
210 mg Oprozomib Tablet
Participants who were administered 210 mg oprozomib tablets.
|
240 mg Oprozomib Tablet
Participants who were administered 240 mg oprozomib tablets.
|
270 mg Oprozomib Tablet
Participants who were administered 270 mg oprozomib tablets.
|
300 mg Oprozomib Tablet
Participants who were administered 300 mg oprozomib tablets.
|
150 mg Oprozomib ER Tablet
Participants who were administered 150 mg extended release oprozomib tablets.
|
300 mg Oprozomib ER Tablet
Participants who were administered 300 mg extended release oprozomib tablets.
|
330 mg Oprozomib ER Tablet
Participants who were administered 330 mg extended release oprozomib tablets.
|
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Response in Phase 2 as Assessed by Investigator
Stringent Complete Response (sCR)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response in Phase 2 as Assessed by Investigator
Complete Response (CR)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response in Phase 2 as Assessed by Investigator
Near Complete Response (nCR)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response in Phase 2 as Assessed by Investigator
Very Good Partial Response (VGPR)
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response in Phase 2 as Assessed by Investigator
Partial Response (PR)
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response in Phase 2 as Assessed by Investigator
Minimal Response (MR)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response in Phase 2 as Assessed by Investigator
Stable Disease (SD)
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response in Phase 2 as Assessed by Investigator
Progressive Disease (PD)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response in Phase 2 as Assessed by Investigator
Not Evaluable (NE)
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response in Phase 2 as Assessed by Investigator
Unknown
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Screening: Day 14 to Day -1; During study: Day 1 up to 13.16 monthsPopulation: Safety Population
The overall response rate (ORR) was defined as the percentage of participants with the best overall response of stringent complete response (sCR), complete response (CR), near complete response (nCR), very good partial response (VGPR), and partial response (PR) as defined by the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) and modified European Group for Blood and Marrow Transplantation (EBMT) criteria.
Outcome measures
| Measure |
Phase 2 300 mg 2/7 Schedule
n=18 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
210 mg Oprozomib Tablet
Participants who were administered 210 mg oprozomib tablets.
|
240 mg Oprozomib Tablet
Participants who were administered 240 mg oprozomib tablets.
|
270 mg Oprozomib Tablet
Participants who were administered 270 mg oprozomib tablets.
|
300 mg Oprozomib Tablet
Participants who were administered 300 mg oprozomib tablets.
|
150 mg Oprozomib ER Tablet
Participants who were administered 150 mg extended release oprozomib tablets.
|
300 mg Oprozomib ER Tablet
Participants who were administered 300 mg extended release oprozomib tablets.
|
330 mg Oprozomib ER Tablet
Participants who were administered 330 mg extended release oprozomib tablets.
|
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an Overall Response As Assessed by Investigator During Phase 2
|
66.7 percentage of participants
Interval 41.0 to 86.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Safety population
PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2
Outcome measures
| Measure |
Phase 2 300 mg 2/7 Schedule
n=9 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
210 mg Oprozomib Tablet
n=9 Participants
Participants who were administered 210 mg oprozomib tablets.
|
240 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 240 mg oprozomib tablets.
|
270 mg Oprozomib Tablet
n=6 Participants
Participants who were administered 270 mg oprozomib tablets.
|
300 mg Oprozomib Tablet
n=5 Participants
Participants who were administered 300 mg oprozomib tablets.
|
150 mg Oprozomib ER Tablet
n=3 Participants
Participants who were administered 150 mg extended release oprozomib tablets.
|
300 mg Oprozomib ER Tablet
n=19 Participants
Participants who were administered 300 mg extended release oprozomib tablets.
|
330 mg Oprozomib ER Tablet
n=6 Participants
Participants who were administered 330 mg extended release oprozomib tablets.
|
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Time to Maximum Serum Concentration (Tmax) on Cycle 1, Day 1
|
1.0 hours
Interval 0.5 to 2.0
|
1.1 hours
Interval 0.5 to 6.0
|
1.0 hours
Interval 0.98 to 2.0
|
1.0 hours
Interval 0.5 to 2.0
|
2.0 hours
Interval 1.0 to 3.9
|
2.0 hours
Interval 1.1 to 4.0
|
1.0 hours
Interval 0.5 to 2.0
|
1.5 hours
Interval 0.47 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Safety population
PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2
Outcome measures
| Measure |
Phase 2 300 mg 2/7 Schedule
n=9 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
210 mg Oprozomib Tablet
n=9 Participants
Participants who were administered 210 mg oprozomib tablets.
|
240 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 240 mg oprozomib tablets.
|
270 mg Oprozomib Tablet
n=6 Participants
Participants who were administered 270 mg oprozomib tablets.
|
300 mg Oprozomib Tablet
n=5 Participants
Participants who were administered 300 mg oprozomib tablets.
|
150 mg Oprozomib ER Tablet
n=3 Participants
Participants who were administered 150 mg extended release oprozomib tablets.
|
300 mg Oprozomib ER Tablet
n=19 Participants
Participants who were administered 300 mg extended release oprozomib tablets.
|
330 mg Oprozomib ER Tablet
n=6 Participants
Participants who were administered 330 mg extended release oprozomib tablets.
|
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Maximum Serum Concentration (Cmax) on Cycle 1, Day 1
|
633 ng/mL
Geometric Coefficient of Variation 192.1
|
754 ng/mL
Geometric Coefficient of Variation 91.7
|
841 ng/mL
Geometric Coefficient of Variation 73.8
|
906 ng/mL
Geometric Coefficient of Variation 69.3
|
881 ng/mL
Geometric Coefficient of Variation 37.8
|
672 ng/mL
Geometric Coefficient of Variation 54.5
|
785 ng/mL
Geometric Coefficient of Variation 63.7
|
578 ng/mL
Geometric Coefficient of Variation 80.1
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Safety population
The area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) was estimated using the linear trapezoidal method. PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2
Outcome measures
| Measure |
Phase 2 300 mg 2/7 Schedule
n=9 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
210 mg Oprozomib Tablet
n=9 Participants
Participants who were administered 210 mg oprozomib tablets.
|
240 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 240 mg oprozomib tablets.
|
270 mg Oprozomib Tablet
n=6 Participants
Participants who were administered 270 mg oprozomib tablets.
|
300 mg Oprozomib Tablet
n=5 Participants
Participants who were administered 300 mg oprozomib tablets.
|
150 mg Oprozomib ER Tablet
n=3 Participants
Participants who were administered 150 mg extended release oprozomib tablets.
|
300 mg Oprozomib ER Tablet
n=19 Participants
Participants who were administered 300 mg extended release oprozomib tablets.
|
330 mg Oprozomib ER Tablet
n=6 Participants
Participants who were administered 330 mg extended release oprozomib tablets.
|
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Area Under the Curve at the Last Measurable Time Point (AUClast) on Cycle 1, Day 1
|
1140 hr*ng/mL
Geometric Coefficient of Variation 197.4
|
1770 hr*ng/mL
Geometric Coefficient of Variation 104.7
|
2170 hr*ng/mL
Geometric Coefficient of Variation 51.8
|
1900 hr*ng/mL
Geometric Coefficient of Variation 68.9
|
2530 hr*ng/mL
Geometric Coefficient of Variation 63.4
|
1690 hr*ng/mL
Geometric Coefficient of Variation 16.1
|
1740 hr*ng/mL
Geometric Coefficient of Variation 70.3
|
1690 hr*ng/mL
Geometric Coefficient of Variation 70.8
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Safety population
The area under the plasma concentration-curve from time 0 to time infinity (AUCinf) was estimated using the linear trapezoidal method PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2
Outcome measures
| Measure |
Phase 2 300 mg 2/7 Schedule
n=7 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
210 mg Oprozomib Tablet
n=6 Participants
Participants who were administered 210 mg oprozomib tablets.
|
240 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 240 mg oprozomib tablets.
|
270 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 270 mg oprozomib tablets.
|
300 mg Oprozomib Tablet
n=5 Participants
Participants who were administered 300 mg oprozomib tablets.
|
150 mg Oprozomib ER Tablet
n=1 Participants
Participants who were administered 150 mg extended release oprozomib tablets.
|
300 mg Oprozomib ER Tablet
n=15 Participants
Participants who were administered 300 mg extended release oprozomib tablets.
|
330 mg Oprozomib ER Tablet
n=4 Participants
Participants who were administered 330 mg extended release oprozomib tablets.
|
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Area Under the Curve From Time 0 to Time Infinity (AUCinf) on Cycle 1, Day 1
|
947 hr*ng/mL
Geometric Coefficient of Variation 229.7
|
1600 hr*ng/mL
Geometric Coefficient of Variation 127.2
|
2180 hr*ng/mL
Geometric Coefficient of Variation 51.6
|
1970 hr*ng/mL
Geometric Coefficient of Variation 88.8
|
2550 hr*ng/mL
Geometric Coefficient of Variation 63.5
|
NA hr*ng/mL
Geometric Coefficient of Variation NA
calculation not performed for a single participant.
|
1900 hr*ng/mL
Geometric Coefficient of Variation 77.7
|
2150 hr*ng/mL
Geometric Coefficient of Variation 27.6
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Safety population
PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2
Outcome measures
| Measure |
Phase 2 300 mg 2/7 Schedule
n=7 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
210 mg Oprozomib Tablet
n=6 Participants
Participants who were administered 210 mg oprozomib tablets.
|
240 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 240 mg oprozomib tablets.
|
270 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 270 mg oprozomib tablets.
|
300 mg Oprozomib Tablet
n=5 Participants
Participants who were administered 300 mg oprozomib tablets.
|
150 mg Oprozomib ER Tablet
n=1 Participants
Participants who were administered 150 mg extended release oprozomib tablets.
|
300 mg Oprozomib ER Tablet
n=15 Participants
Participants who were administered 300 mg extended release oprozomib tablets.
|
330 mg Oprozomib ER Tablet
n=4 Participants
Participants who were administered 330 mg extended release oprozomib tablets.
|
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Terminal Half-Life (t1/2,z) on Cycle 1, Day 1
|
0.962 hr
Geometric Coefficient of Variation 40.6
|
0.573 hr
Geometric Coefficient of Variation 29.4
|
0.970 hr
Geometric Coefficient of Variation 79.2
|
0.850 hr
Geometric Coefficient of Variation 29.5
|
1.36 hr
Geometric Coefficient of Variation 80.1
|
NA hr
Geometric Coefficient of Variation NA
calculation not performed for a single participant.
|
0.710 hr
Geometric Coefficient of Variation 40.7
|
0.805 hr
Geometric Coefficient of Variation 40.1
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Safety population
The apparent drug clearance after oral administration (CL/F) was calculated as the dose divided by AUCinf. PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2
Outcome measures
| Measure |
Phase 2 300 mg 2/7 Schedule
n=7 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
210 mg Oprozomib Tablet
n=6 Participants
Participants who were administered 210 mg oprozomib tablets.
|
240 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 240 mg oprozomib tablets.
|
270 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 270 mg oprozomib tablets.
|
300 mg Oprozomib Tablet
n=5 Participants
Participants who were administered 300 mg oprozomib tablets.
|
150 mg Oprozomib ER Tablet
n=1 Participants
Participants who were administered 150 mg extended release oprozomib tablets.
|
300 mg Oprozomib ER Tablet
n=15 Participants
Participants who were administered 300 mg extended release oprozomib tablets.
|
330 mg Oprozomib ER Tablet
n=4 Participants
Participants who were administered 330 mg extended release oprozomib tablets.
|
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Apparent Drug Clearance After Oral Administration (CL/F) on Cycle 1, Day 1
|
190000 mL/hr
Geometric Coefficient of Variation 229.7
|
131000 mL/hr
Geometric Coefficient of Variation 127.2
|
110000 mL/hr
Geometric Coefficient of Variation 51.6
|
137000 mL/hr
Geometric Coefficient of Variation 88.8
|
118000 mL/hr
Geometric Coefficient of Variation 63.5
|
NA mL/hr
Geometric Coefficient of Variation NA
calculation not performed for a single participant.
|
157000 mL/hr
Geometric Coefficient of Variation 77.7
|
153000 mL/hr
Geometric Coefficient of Variation 27.6
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Safety population
The apparent volume of distribution after oral administration (Vz/F) calculated as the dose divided by AUCinf times ƒz, where ƒz was the first-order terminal rate constant estimated via linear regression of the terminal log-linear phase. PK samples obtained on the following schedule: Phase 1b Continuous Dosing, Cycles 1 and 2: Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 8 hours post-dose plus pre-dose on Day 2 Phase 1b Step-up Dosing, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2 Phase 2, Day 1: pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, and 7 hours post-dose plus pre-dose on Day 2
Outcome measures
| Measure |
Phase 2 300 mg 2/7 Schedule
n=7 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
210 mg Oprozomib Tablet
n=6 Participants
Participants who were administered 210 mg oprozomib tablets.
|
240 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 240 mg oprozomib tablets.
|
270 mg Oprozomib Tablet
n=4 Participants
Participants who were administered 270 mg oprozomib tablets.
|
300 mg Oprozomib Tablet
n=5 Participants
Participants who were administered 300 mg oprozomib tablets.
|
150 mg Oprozomib ER Tablet
n=1 Participants
Participants who were administered 150 mg extended release oprozomib tablets.
|
300 mg Oprozomib ER Tablet
n=15 Participants
Participants who were administered 300 mg extended release oprozomib tablets.
|
330 mg Oprozomib ER Tablet
n=4 Participants
Participants who were administered 330 mg extended release oprozomib tablets.
|
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter for Oprozomib, Tablet and ER Formulation: Apparent Volume of Distribution After Oral Administration (Vz/F) on Cycle 1, Day 1
|
264000 mL
Geometric Coefficient of Variation 235.6
|
108000 mL
Geometric Coefficient of Variation 106.7
|
154000 mL
Geometric Coefficient of Variation 79.5
|
168000 mL
Geometric Coefficient of Variation 138.9
|
231000 mL
Geometric Coefficient of Variation 54.7
|
NA mL
Geometric Coefficient of Variation NA
calculation not performed for a single participant.
|
161000 mL
Geometric Coefficient of Variation 69.0
|
178000 mL
Geometric Coefficient of Variation 44.3
|
—
|
SECONDARY outcome
Timeframe: Screening: Day 14 to Day -1; During study: Day 1 up to 13.16 monthsPopulation: Safety Population
The clinical benefit rate (CBR) was defined as Overall Response Rate (ORR) plus Minimal Response (MR) as defined by the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Outcome measures
| Measure |
Phase 2 300 mg 2/7 Schedule
n=18 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
210 mg Oprozomib Tablet
Participants who were administered 210 mg oprozomib tablets.
|
240 mg Oprozomib Tablet
Participants who were administered 240 mg oprozomib tablets.
|
270 mg Oprozomib Tablet
Participants who were administered 270 mg oprozomib tablets.
|
300 mg Oprozomib Tablet
Participants who were administered 300 mg oprozomib tablets.
|
150 mg Oprozomib ER Tablet
Participants who were administered 150 mg extended release oprozomib tablets.
|
300 mg Oprozomib ER Tablet
Participants who were administered 300 mg extended release oprozomib tablets.
|
330 mg Oprozomib ER Tablet
Participants who were administered 330 mg extended release oprozomib tablets.
|
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved a Clinical Benefit Response As Assessed by Investigator During Phase 2
|
72.2 percentage of participants
Interval 46.5 to 90.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to 13.16 monthsPopulation: Safety population
Duration of response was defined as the time from first evidence of partial response (PR) or better (i.e. best overall response) to confirmation of disease progression or death due to any cause. Durations were calculated for responders only. Medians and percentiles were estimated using the Kaplan-Meier method. 95% confidence intervals for medians and percentiles were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.
Outcome measures
| Measure |
Phase 2 300 mg 2/7 Schedule
n=18 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
210 mg Oprozomib Tablet
Participants who were administered 210 mg oprozomib tablets.
|
240 mg Oprozomib Tablet
Participants who were administered 240 mg oprozomib tablets.
|
270 mg Oprozomib Tablet
Participants who were administered 270 mg oprozomib tablets.
|
300 mg Oprozomib Tablet
Participants who were administered 300 mg oprozomib tablets.
|
150 mg Oprozomib ER Tablet
Participants who were administered 150 mg extended release oprozomib tablets.
|
300 mg Oprozomib ER Tablet
Participants who were administered 300 mg extended release oprozomib tablets.
|
330 mg Oprozomib ER Tablet
Participants who were administered 330 mg extended release oprozomib tablets.
|
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Kaplan-Meier Estimates for Duration of Response (DOR) as Assessed by Investigator During Phase 2
|
NA months
Interval 6.8 to
not enough events to calculate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to 14.1 monthsPopulation: Safety population
Progression-free survival (PFS) was defined as number of months between start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurs first. Disease progression was determined using IMWG-URC per investigator. The duration of PFS was right-censored for participants who met 1 of the following conditions: * 1\) starting a new anticancer therapy before documentation of disease progression or death; * 2\) death or disease progression immediately after more than 1 consecutively missed disease assessment visit or; * 3\) alive without documentation of disease progression before the data cutoff date. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.
Outcome measures
| Measure |
Phase 2 300 mg 2/7 Schedule
n=18 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
210 mg Oprozomib Tablet
Participants who were administered 210 mg oprozomib tablets.
|
240 mg Oprozomib Tablet
Participants who were administered 240 mg oprozomib tablets.
|
270 mg Oprozomib Tablet
Participants who were administered 270 mg oprozomib tablets.
|
300 mg Oprozomib Tablet
Participants who were administered 300 mg oprozomib tablets.
|
150 mg Oprozomib ER Tablet
Participants who were administered 150 mg extended release oprozomib tablets.
|
300 mg Oprozomib ER Tablet
Participants who were administered 300 mg extended release oprozomib tablets.
|
330 mg Oprozomib ER Tablet
Participants who were administered 330 mg extended release oprozomib tablets.
|
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Kaplan-Meier Estimates for Progression-free Survival (PFS) as Assessed by Investigator During Phase 2
|
12.2 months
Interval 3.5 to
not enough events to calculate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to 14.1 monthsPopulation: Safety population
Time to progression (TTP) was defined as the number of months between the start of treatment to the first documentation of disease progression. Disease progression was determined using IMWG-URC as assessed by the investigator. The same censoring rules, except for death, as in analysis of PFS were applied in the calculation of TTP. Participants who died prior to progressive disease were censored at the date of last evaluable response assessment.
Outcome measures
| Measure |
Phase 2 300 mg 2/7 Schedule
n=18 Participants
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
210 mg Oprozomib Tablet
Participants who were administered 210 mg oprozomib tablets.
|
240 mg Oprozomib Tablet
Participants who were administered 240 mg oprozomib tablets.
|
270 mg Oprozomib Tablet
Participants who were administered 270 mg oprozomib tablets.
|
300 mg Oprozomib Tablet
Participants who were administered 300 mg oprozomib tablets.
|
150 mg Oprozomib ER Tablet
Participants who were administered 150 mg extended release oprozomib tablets.
|
300 mg Oprozomib ER Tablet
Participants who were administered 300 mg extended release oprozomib tablets.
|
330 mg Oprozomib ER Tablet
Participants who were administered 330 mg extended release oprozomib tablets.
|
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Kaplan-Meier Estimate for Time to Progression (TTP) as Assessed by Investigator During Phase 2
|
12.2 months
Interval 3.5 to
not enough events to calculate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 180 mg 5/14 Schedule (Phase 1b)
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 210 mg 5/14 Schedule (Phase 1b)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Cohort 150/180 mg 5/14 Schedule (Phase 1b)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 210 mg 2/7 Schedule (Phase 1b)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 240 mg 2/7 Schedule (Phase 1b)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Cohort 270 mg 2/7 Schedule (Phase 1b)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 300 mg 2/7 Schedule (Phase 1b)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 330 mg 2/7 Schedule (Phase 1b)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2 300 mg 2/7 Schedule
Serious events: 9 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 180 mg 5/14 Schedule (Phase 1b)
n=9 participants at risk
Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule).
Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 210 mg 5/14 Schedule (Phase 1b)
n=7 participants at risk
Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule).
Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.
|
Cohort 150/180 mg 5/14 Schedule (Phase 1b)
n=3 participants at risk
Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward.
Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 210 mg 2/7 Schedule (Phase 1b)
n=4 participants at risk
Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.
|
Cohort 240 mg 2/7 Schedule (Phase 1b)
n=4 participants at risk
Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 270 mg 2/7 Schedule (Phase 1b)
n=6 participants at risk
Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 300 mg 2/7 Schedule (Phase 1b)
n=8 participants at risk
Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 330 mg 2/7 Schedule (Phase 1b)
n=6 participants at risk
Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Phase 2 300 mg 2/7 Schedule
n=18 participants at risk
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14- day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
3/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Cohort 180 mg 5/14 Schedule (Phase 1b)
n=9 participants at risk
Oprozomib 180 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule).
Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 210 mg 5/14 Schedule (Phase 1b)
n=7 participants at risk
Oprozomib 210 mg treatment once daily for 5 consecutive days bimonthly (days 1, 2, 3, 4, and 5 of a 14-day cycle) with 20 mg dexamethasone once daily on days 1, 2, 8, and 9 (referred to as the 5/14 schedule).
Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason. This was the first cohort to enroll participants into the 5/14 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.
|
Cohort 150/180 mg 5/14 Schedule (Phase 1b)
n=3 participants at risk
Oprozomib 150 mg once daily treatment for 5 consecutive days (days 1, 2, 3, 4, and 5 of a 14-day cycle) followed by a step-up in oprozomib once daily dose to 180 mg starting in cycle 2 and moving forward.
Dexamethasone 20 mg once daily was administered on days 1, 2, 8, and 9 of each 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 210 mg 2/7 Schedule (Phase 1b)
n=4 participants at risk
Oprozomib 210 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
This was the first cohort to enroll participants into the 2/7 schedule. The Cohort Safety Review Committee (CSRC) reviewed safety data and made dose adjustments for oprozomib in 30 mg increments for all cohorts.
|
Cohort 240 mg 2/7 Schedule (Phase 1b)
n=4 participants at risk
Oprozomib 240 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 270 mg 2/7 Schedule (Phase 1b)
n=6 participants at risk
Oprozomib 270 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 300 mg 2/7 Schedule (Phase 1b)
n=8 participants at risk
Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Cohort 330 mg 2/7 Schedule (Phase 1b)
n=6 participants at risk
Oprozomib 330 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
Phase 2 300 mg 2/7 Schedule
n=18 participants at risk
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14- day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
3/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
62.5%
5/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
3/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
44.4%
8/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
37.5%
3/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
22.2%
4/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Arrhythmia
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
3/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Cataract
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Visual impairment
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
38.9%
7/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
2/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
6/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
3/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
22.2%
4/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
2/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
4/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
83.3%
5/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
55.6%
10/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
88.9%
8/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
85.7%
6/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
4/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
75.0%
3/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
6/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
87.5%
7/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
83.3%
5/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
77.8%
14/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
22.2%
2/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
3/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
2/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
6/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Eructation
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
37.5%
3/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lip haematoma
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
88.9%
8/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
7/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
3/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
4/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
75.0%
3/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
83.3%
5/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
87.5%
7/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
6/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
12/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
6/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
71.4%
5/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
3/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
4/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
75.0%
3/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
83.3%
5/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
44.4%
8/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
44.4%
8/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
22.2%
2/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
3/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Discomfort
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Facial pain
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
66.7%
6/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
57.1%
4/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
2/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
2/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
4/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
87.5%
7/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
100.0%
6/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
38.9%
7/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Feeling abnormal
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Feeling jittery
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Gait disturbance
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Nodule
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Oedema
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
27.8%
5/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
22.2%
2/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
2/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
27.8%
5/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Candida infection
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
22.2%
2/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
3/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
37.5%
3/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
83.3%
5/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
22.2%
2/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Animal bite
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase decreased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase decreased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
3/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
33.3%
3/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure abnormal
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood urea decreased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Blood uric acid decreased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Cardiac murmur
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
22.2%
2/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Protein total increased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
3/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count increased
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Cell death
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
55.6%
5/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
75.0%
3/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
27.8%
5/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
2/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
22.2%
2/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
3/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
2/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
44.4%
4/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
22.2%
2/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
6/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
3/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
3/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
33.3%
3/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
37.5%
3/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
3/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
22.2%
4/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
2/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
37.5%
3/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
6/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tremor
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
3/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
28.6%
2/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
2/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
22.2%
4/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Thinking abnormal
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Breast disorder
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
2/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
6/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.2%
2/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
22.2%
2/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
3/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
66.7%
2/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
50.0%
2/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Chronic papillomatous dermatitis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Joint surgery
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Medical device implantation
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Haematoma
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
33.3%
3/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
1/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
12.5%
1/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
14.3%
1/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
25.0%
1/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
11.1%
2/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
33.3%
2/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
16.7%
1/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Post thrombotic syndrome
|
0.00%
0/9 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/7 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/3 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/4 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/8 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
0.00%
0/6 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
5.6%
1/18 • All-cause Mortality - Death that occurred from the date of enrollment until the data cutoff of 30 July 2019. Treatment-emergent adverse events - Day 1 up to Week 282
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER