Trial Outcomes & Findings for A Study of Oprozomib, Pomalidomide, and Dexamethasone in Adults With Primary Refractory or Relapsed and Refractory Multiple Myeloma (NCT NCT01999335)
NCT ID: NCT01999335
Last Updated: 2021-04-27
Results Overview
DLTs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, defined as any of the following treatment-related events occurring within 4 weeks after the first dose of therapy: Any grade ≥ 3 nonhematologic toxicity, except: Grade 3 asymptomatic electrolyte abnormalities or hypophosphatemia for \< 24 hours; Grade 3 nausea, vomiting or diarrhea unless for \> 3 days despite optimal supportive care; Grade 3 fatigue for \< 14 days; Grade ≥ 3 hyperglycemia or toxicity attributed to dexamethasone and Grade ≥ 3 rash attributed to pomalidomide. Hematologic toxicities: * Grade 4 neutropenia: Absolute neutrophil count \< 0.5 × 10\^9/L for ≥ 7 days despite adequate growth factor support; febrile neutropenia * Thrombocytopenia: Grade 4 for ≥ 7 days, or Grade 4 for \< 7 days with grade 2 clinically significant bleeding or \< 10,000 platelets requiring transfusion, or Grade 3 with clinically significant bleeding or requiring platelet transfusion.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
Cycle 1, 28 days
Results posted on
2021-04-27
Participant Flow
This study was conducted at 12 centers in the United States. This study was composed of 2 parts: part 1 was a phase 1b, open-label, dose-escalation and dose-expansion component and part 2 was to have been a phase 3, placebo-controlled, double-blind, randomized component. Part 2 was not conducted.
In part 1 participants were enrolled sequentially using a standard 3 + 3 dose escalation schema. Additional participants were to be enrolled in the dose expansion portion once the recommended dose and schedule had been selected; enrollment was halted after 12 participants were enrolled in the expansion cohort.
Participant milestones
| Measure |
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
7
|
10
|
12
|
|
Overall Study
Received Study Treatment
|
3
|
1
|
7
|
10
|
10
|
|
Overall Study
COMPLETED
|
3
|
1
|
7
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
Discontinued before receiving treatment
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A Study of Oprozomib, Pomalidomide, and Dexamethasone in Adults With Primary Refractory or Relapsed and Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
n=3 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
n=1 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=7 Participants
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=10 Participants
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
n=10 Participants
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
59.0 years
n=7 Participants
|
57.1 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
68.2 years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
63.7 years
STANDARD_DEVIATION 6.0 • n=21 Participants
|
62.6 years
STANDARD_DEVIATION 9.3 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
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=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0 (Fully active)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1 (Restricted but ambulatory)
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 2 (Ambulatory but unable to work)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Cycle 1, 28 daysPopulation: Participants who received at least 1 dose of any study drug
DLTs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, defined as any of the following treatment-related events occurring within 4 weeks after the first dose of therapy: Any grade ≥ 3 nonhematologic toxicity, except: Grade 3 asymptomatic electrolyte abnormalities or hypophosphatemia for \< 24 hours; Grade 3 nausea, vomiting or diarrhea unless for \> 3 days despite optimal supportive care; Grade 3 fatigue for \< 14 days; Grade ≥ 3 hyperglycemia or toxicity attributed to dexamethasone and Grade ≥ 3 rash attributed to pomalidomide. Hematologic toxicities: * Grade 4 neutropenia: Absolute neutrophil count \< 0.5 × 10\^9/L for ≥ 7 days despite adequate growth factor support; febrile neutropenia * Thrombocytopenia: Grade 4 for ≥ 7 days, or Grade 4 for \< 7 days with grade 2 clinically significant bleeding or \< 10,000 platelets requiring transfusion, or Grade 3 with clinically significant bleeding or requiring platelet transfusion.
Outcome measures
| Measure |
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
n=3 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
n=1 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=7 Participants
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=10 Participants
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
n=10 Participants
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLTs)
Any dose-limiting toxicity
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Dose-limiting Toxicities (DLTs)
Gastric hemorrhage
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Dose-limiting Toxicities (DLTs)
Abdominal distension
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Dose-limiting Toxicities (DLTs)
Mucosal inflammation
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Dose-limiting Toxicities (DLTs)
Cognitive disorder
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of any study drug up to 30 days after the last dose; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.Population: Participants who received at least 1 dose of any study drug
Adverse events (AEs) were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 and according to the following: Grade 1 = mild AE, Grade 2 = Moderate AE, Grade 3 = a severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE. A serious AE is an event that met 1 or more of the following criteria: * Death * Life-threatening experience * Required inpatient hospitalization or prolongation of an existing hospitalization * Resulted in persistent or significant disability/incapacity * A congenital anomaly birth defect in the offspring of an exposed female subject or offspring of a female partner of a male subject * Important medical events that, based upon appropriate medical judgment, jeopardized the participant and may have required medical or surgical intervention to prevent an outcome listed above. Treatment-related AEs (TRAE) are those considered related to at least 1 study drug by the investigator.
Outcome measures
| Measure |
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
n=3 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
n=1 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=7 Participants
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=10 Participants
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
n=10 Participants
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Any treatment-emergent adverse event
|
3 Participants
|
1 Participants
|
7 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs leading to discontinuation of study drug
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Treatment-related TEAE Grade ≥ 3
|
2 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAE Grade ≥ 3
|
2 Participants
|
1 Participants
|
5 Participants
|
9 Participants
|
9 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Serious adverse events
|
0 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Fatal adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Treatment-related treatment-emergent adverse events (TRAE)
|
3 Participants
|
1 Participants
|
7 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Treatment-related serious adverse events
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TRAEs leading to discontinuation of study drug
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Treatment-related fatal adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Cycles 1 and 2 days 1, 5, 15, and 19 and days 3 and 8 of cycle 1, and day 1 of each cycle from cycle 3 thereafter until the end of treatment; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.Population: Participants who received at least 1 dose of any study drug
Laboratory abnormalities were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03). Full chemistry panel included sodium, potassium, calcium, alkaline phosphatase, blood urea nitrogen, uric acid, lactate dehydrogenase, creatinine, chloride, bicarbonate, glucose, total protein, albumin, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), phosphorous, and magnesium. Complete blood count (CBC) with differential included hemoglobin, hematocrit, white blood cell (WBC) count with complete manual or automated differential (total neutrophils, lymphocytes, monocytes, eosinophils, basophils; reported as absolute counts), red blood cell (RBC) count, and platelet count.
Outcome measures
| Measure |
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
n=3 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
n=1 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=7 Participants
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=10 Participants
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
n=10 Participants
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Number of Participants With Post-Baseline Grade 3 or 4 Laboratory Toxicities
Grade 3 increase in total bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Grade 3 or 4 Laboratory Toxicities
Grade 4 decrease in magnesium
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Grade 3 or 4 Laboratory Toxicities
Grade 3 decrease in leukocytes
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Post-Baseline Grade 3 or 4 Laboratory Toxicities
Grade 3 decrease in neutrophils
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Post-Baseline Grade 3 or 4 Laboratory Toxicities
Grade 4 decrease in lymphocytes
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Grade 3 or 4 Laboratory Toxicities
Grade 3 decrease in platelets
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Post-Baseline Grade 3 or 4 Laboratory Toxicities
Grade 4 decrease in sodium
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Grade 3 or 4 Laboratory Toxicities
At least 1 Grade 3 or 4 laboratory toxicity
|
2 Participants
|
1 Participants
|
6 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With Post-Baseline Grade 3 or 4 Laboratory Toxicities
Grade 3 increase in glucose
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Post-Baseline Grade 3 or 4 Laboratory Toxicities
Grade 4 increase in glucose
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Grade 3 or 4 Laboratory Toxicities
Grade 3 increase in magnesium
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Post-Baseline Grade 3 or 4 Laboratory Toxicities
Grade 3 decrease in sodium
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Post-Baseline Grade 3 or 4 Laboratory Toxicities
Grade 3 decrease in hemoglobin
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Post-Baseline Grade 3 or 4 Laboratory Toxicities
Grade 3 decrease in lymphocytes
|
1 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Post-Baseline Grade 3 or 4 Laboratory Toxicities
Grade 4 decrease in leukocytes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Post-Baseline Grade 3 or 4 Laboratory Toxicities
Grade 4 decrease in neutrophils
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Disease response was assessed every 4 weeks for the first 18 months and then every 8 weeks for the remainder of study treatment; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.Population: Participants who received at least 1 dose of any study drug
ORR is defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR), or stringent CR (sCR) based on the International Myeloma Working Group Uniform Response Criteria. PR: ≥ 50% reduction of serum M-protein and ≥90% reduction in urine M-protein or to \< 200 mg/24 hrs, or a ≥50% decrease in the difference between involved and uninvolved free light chain levels (dFLC). A ≥ 50% decrease in the size of soft tissue plasmacytomas present at baseline. VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% decrease in serum M-protein with urine M-protein \<100 mg/24 hrs. If disease measurable only by serum FLC (SFLC), ≥ 90% decrease in dFLC. CR: No immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and \<5% plasma cells in bone marrow (BM). Normal SFLC ratio if disease measurable only by SFLC. sCR: As for CR, and absence of clonal plasma cells in BM.
Outcome measures
| Measure |
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
n=3 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
n=1 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=7 Participants
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=10 Participants
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
n=10 Participants
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
60.0 percentage of participants
Interval 26.2 to 87.8
|
60.0 percentage of participants
Interval 26.2 to 87.8
|
SECONDARY outcome
Timeframe: Disease response was assessed every 4 weeks for the first 18 months and then every 8 weeks for the remainder of study treatment; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.Population: Participants who received at least 1 dose of any study drug
Clinical benefit rate is defined as the percentage of participants with a best overall response of minimal response (MR) per modified European Group for Blood and Marrow Transplantation criteria, or PR, VGPR, CR, or sCR as determined by the investigator according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). MR: * ≥ 25% but \< 49% reduction in serum M-protein and a 50 - 89% reduction in 24-hour urinary M-protein, which still exceeds 200 mg per 24 hours * If the serum and urine M-protein were not measurable, a decrease of 25 - 49% in the difference between involved and uninvolved FLC levels was required in place of the M-protein criteria. * For patients with nonsecretory myeloma only, 25 - 49% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed * 25 - 49% reduction in the size of soft tissue plasmacytomas (by radiography or clinical examination)
Outcome measures
| Measure |
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
n=3 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
n=1 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=7 Participants
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=10 Participants
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
n=10 Participants
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Clinical Benefit Rate (CBR)
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
60.0 percentage of participants
Interval 26.2 to 87.8
|
60.0 percentage of participants
Interval 26.2 to 87.8
|
SECONDARY outcome
Timeframe: Cycle 1 day 1 at predose and 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours postdose. Cycle 2 day 1 at predose and 0.25, 0.5, 1, 2, 3, 4, and 6 hours postdose.Population: Participants with adequate oprozomib plasma concentration-versus-time data to allow estimation of pharmacokinetic (PK) parameters. Treatment groups receiving the same dose of oprozomib were combined for PK analyses.
Oprozomib plasma concentrations were determined using liquid chromatography with tandem mass spectrometry.
Outcome measures
| Measure |
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
n=3 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
n=16 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=9 Participants
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Oprozomib
Cycle 1 day 1
|
492 ng/mL
Geometric Coefficient of Variation 398.3
|
744 ng/mL
Geometric Coefficient of Variation 119.4
|
757 ng/mL
Geometric Coefficient of Variation 38.7
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) of Oprozomib
Cycle 2 day 1
|
181 ng/mL
Geometric Coefficient of Variation 401.1
|
1030 ng/mL
Geometric Coefficient of Variation 91.5
|
965 ng/mL
Geometric Coefficient of Variation 44.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 day 1 at predose and 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours postdose. Cycle 2 day 1 at predose and 0.25, 0.5, 1, 2, 3, 4, and 6 hours postdose.Population: Participants with adequate oprozomib plasma concentration-versus-time data to allow estimation of pharmacokinetic (PK) parameters. Treatment groups receiving the same dose of oprozomib were combined for PK analyses.
Oprozomib plasma concentrations were determined using liquid chromatography with tandem mass spectrometry.
Outcome measures
| Measure |
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
n=3 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
n=16 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=9 Participants
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of Oprozomib
Cycle 1 day 1
|
1.0 hours
Interval 1.0 to 6.1
|
1.6 hours
Interval 0.5 to 6.1
|
2.2 hours
Interval 1.1 to 3.8
|
—
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of Oprozomib
Cycle 2 day 1
|
4.0 hours
Interval 1.0 to 4.1
|
1.1 hours
Interval 0.42 to 4.0
|
1.1 hours
Interval 0.63 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 day 1 at predose and 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours postdose. Cycle 2 day 1 at predose and 0.25, 0.5, 1, 2, 3, 4, and 6 hours postdose.Population: Participants with adequate oprozomib plasma concentration-versus-time data to allow estimation of pharmacokinetic (PK) parameters. Treatment groups receiving the same dose of oprozomib were combined for PK analyses.
Oprozomib plasma concentrations were determined using liquid chromatography with tandem mass spectrometry. The area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUClast) was estimated using the linear trapezoidal method.
Outcome measures
| Measure |
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
n=3 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
n=16 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=9 Participants
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of Oprozomib
Cycle 1 day 1
|
1090 hr*ng/mL
Geometric Coefficient of Variation 192.2
|
1700 hr*ng/mL
Geometric Coefficient of Variation 145.9
|
1730 hr*ng/mL
Geometric Coefficient of Variation 48.7
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of Oprozomib
Cycle 2 day 1
|
446 hr*ng/mL
Geometric Coefficient of Variation 605.7
|
1860 hr*ng/mL
Geometric Coefficient of Variation 81.9
|
1800 hr*ng/mL
Geometric Coefficient of Variation 17.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 day 1 at predose and 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours postdose. Cycle 2 day 1 at predose and 0.25, 0.5, 1, 2, 3, 4, and 6 hours postdose.Population: Participants with adequate oprozomib plasma concentration-versus-time data to allow estimation of pharmacokinetic (PK) parameters. Treatment groups receiving the same dose of oprozomib were combined for PK analyses.
Oprozomib plasma concentrations were determined using liquid chromatography with tandem mass spectrometry. The area under the plasma concentration-time curve from time 0 to time infinity (AUCinf), estimated as the sum of AUClast and Clast/λz, where Clast is the last predicted concentration and λz is the first-order terminal rate constant estimated via linear regression of the terminal log-linear decay phase.
Outcome measures
| Measure |
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
n=2 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
n=8 Participants
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=5 Participants
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Time Infinity (AUCinf) of Oprozomib
Cycle 1 day 1
|
2250 hr*ng/mL
Geometric Coefficient of Variation NA
Not calculated when N ≤ 2
|
3440 hr*ng/mL
Geometric Coefficient of Variation 96.1
|
1660 hr*ng/mL
Geometric Coefficient of Variation 35.8
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Time Infinity (AUCinf) of Oprozomib
Cycle 2 day 1
|
—
|
1830 hr*ng/mL
Geometric Coefficient of Variation 87.7
|
1900 hr*ng/mL
Geometric Coefficient of Variation 12.4
|
—
|
—
|
Adverse Events
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
Serious events: 3 serious events
Other events: 7 other events
Deaths: 4 deaths
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
Serious events: 6 serious events
Other events: 10 other events
Deaths: 3 deaths
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
Serious events: 6 serious events
Other events: 10 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
n=3 participants at risk
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
n=1 participants at risk
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=7 participants at risk
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=10 participants at risk
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
n=10 participants at risk
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
GASTRIC HAEMORRHAGE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
General disorders
PYREXIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
ABSCESS JAW
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
ORAL INFECTION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
PARAINFLUENZAE VIRUS INFECTION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
PLEURAL INFECTION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOTHORAX
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
Other adverse events
| Measure |
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
n=3 participants at risk
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
n=1 participants at risk
Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=7 participants at risk
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
n=10 participants at risk
Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
n=10 participants at risk
Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
42.9%
3/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
40.0%
4/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
70.0%
7/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Blood and lymphatic system disorders
HYPERCOAGULATION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Blood and lymphatic system disorders
INCREASED TENDENCY TO BRUISE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
42.9%
3/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
60.0%
6/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Eye disorders
CATARACT
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Eye disorders
DRY EYE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Eye disorders
EYE HAEMATOMA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Eye disorders
EYE IRRITATION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Eye disorders
LACRIMATION INCREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Eye disorders
PERIORBITAL OEDEMA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Eye disorders
SCLERAL HAEMORRHAGE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Eye disorders
VISION BLURRED
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
40.0%
4/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
CONSTIPATION
|
66.7%
2/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
42.9%
3/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
60.0%
6/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
60.0%
6/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
DENTAL DISCOMFORT
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
66.7%
2/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
7/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
90.0%
9/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
80.0%
8/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
DIVERTICULAR PERFORATION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
42.9%
3/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
ERUCTATION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
FLATULENCE
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
FREQUENT BOWEL MOVEMENTS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
HYPOAESTHESIA ORAL
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
71.4%
5/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
10/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
50.0%
5/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
OESOPHAGEAL PAIN
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
TOOTH LOSS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Gastrointestinal disorders
VOMITING
|
66.7%
2/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
57.1%
4/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
80.0%
8/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
60.0%
6/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
General disorders
ASTHENIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
General disorders
CHEST PAIN
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
General disorders
CHILLS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
General disorders
FACE OEDEMA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
General disorders
FATIGUE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
85.7%
6/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
70.0%
7/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
80.0%
8/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
General disorders
GAIT DISTURBANCE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
General disorders
MALAISE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
General disorders
MUCOSAL INFLAMMATION
|
66.7%
2/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
General disorders
OEDEMA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
General disorders
PAIN
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
General disorders
PYREXIA
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
General disorders
SWELLING
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
CANDIDA INFECTION
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
EYE INFECTION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
FUNGAL INFECTION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
PAROTITIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
SALMONELLOSIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
66.7%
2/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
57.1%
4/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
40.0%
4/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
SKIN ABRASION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Injury, poisoning and procedural complications
WOUND
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
BLOOD LACTIC ACID INCREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
BLOOD THYROID STIMULATING HORMONE INCREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
GLOMERULAR FILTRATION RATE DECREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR DECREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
INTERNATIONAL NORMALISED RATIO DECREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
40.0%
4/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
PROTEIN TOTAL DECREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
WEIGHT DECREASED
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
40.0%
4/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
HYPERCHLORAEMIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
HYPERMAGNESAEMIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATAEMIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
40.0%
4/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
50.0%
5/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
42.9%
3/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
42.9%
3/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
JAW DISORDER
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
42.9%
3/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
66.7%
2/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
AMNESIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
APHASIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
COGNITIVE DISORDER
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
DEMENTIA ALZHEIMER'S TYPE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
40.0%
4/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
DYSGEUSIA
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
40.0%
4/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
HYPERSOMNIA
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
40.0%
4/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
40.0%
4/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Psychiatric disorders
MOOD ALTERED
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Psychiatric disorders
MOOD SWINGS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Psychiatric disorders
RESTLESSNESS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
42.9%
3/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
HYPERCAPNIA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT CONGESTION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
30.0%
3/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS PAIN
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
RASH
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
100.0%
1/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
33.3%
1/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
20.0%
2/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
28.6%
2/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Vascular disorders
PHLEBITIS
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
10.0%
1/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
|
Vascular disorders
VASCULAR RUPTURE
|
0.00%
0/3 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/1 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
14.3%
1/7 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any study drug.
|
0.00%
0/10 • All-cause mortality: From the date of enrollment until the data cutoff of 25 April 2019, a maximum of 51 months. Treatment-emergent adverse events: From the first dose of any study treatment and within the end of study or 30 days of the last dose of any study treatment, whichever occurred earlier; median duration of treatment was 7.6, 28.0, 32.1, 46.3, and 17.4 weeks in each treatment group, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of any 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