Trial Outcomes & Findings for Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML) (NCT NCT02343939)
NCT ID: NCT02343939
Last Updated: 2019-11-15
Results Overview
DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment. DLT assessment was applicable only for Phase 1b and Phase 2 safety run-in participants.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
148 participants
Primary outcome timeframe
Group A: Cycle 0 Day 1 to Cycle 2 Day 28; Group B: Cycle 0 Day 1 to Cycle 1 Day 28; Group C: Cycle 1 Day 1 to Cycle 1 Day 28 (Cycle length: for Cycle 0 = 14 days, for all other cycles = 28 days)
Results posted on
2019-11-15
Participant Flow
Participants were enrolled at study sites in United States, Canada, and Germany. The first participant was screened on 01 July 2015.
233 participants were screened.
Participant milestones
| Measure |
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
|
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m\^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m\^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
|
Group B Phase 1b ENTO 200 mg + Decitabine
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 1b ENTO 400 mg + Decitabine
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b/2 ENTO 400 mg
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
50
|
5
|
6
|
8
|
17
|
15
|
37
|
7
|
|
Overall Study
COMPLETED
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
48
|
5
|
6
|
8
|
17
|
15
|
37
|
7
|
Reasons for withdrawal
| Measure |
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
|
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m\^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m\^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
|
Group B Phase 1b ENTO 200 mg + Decitabine
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 1b ENTO 400 mg + Decitabine
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b/2 ENTO 400 mg
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
15
|
4
|
2
|
5
|
11
|
8
|
22
|
1
|
|
Overall Study
Study terminated by sponsor
|
0
|
27
|
0
|
1
|
1
|
5
|
3
|
4
|
0
|
|
Overall Study
Withdrew consent
|
3
|
6
|
1
|
2
|
2
|
0
|
0
|
8
|
6
|
|
Overall Study
Treatment failure
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Overall Study
Investigator's discretion
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Never Treated With ENTO
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
Baseline Characteristics
Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
n=3 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
|
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
n=50 Participants
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m\^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m\^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
|
Group B Phase 1b ENTO 200 mg + Decitabine
n=5 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 1b ENTO 400 mg + Decitabine
n=6 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
n=8 Participants
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
n=17 Participants
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
n=14 Participants
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b/2 ENTO 400 mg
n=35 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=7 Participants
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
< 65 Years
|
3 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
17 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
55 Participants
n=42 Participants
|
|
Age, Customized
≥ 65 years
|
0 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
18 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
90 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
18 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
61 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
17 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
84 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
33 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
137 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
3 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
31 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
125 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · 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=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
29 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
130 Participants
n=42 Participants
|
|
Region of Enrollment
Germany
|
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
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Group A: Cycle 0 Day 1 to Cycle 2 Day 28; Group B: Cycle 0 Day 1 to Cycle 1 Day 28; Group C: Cycle 1 Day 1 to Cycle 1 Day 28 (Cycle length: for Cycle 0 = 14 days, for all other cycles = 28 days)Population: The DLT Analysis Set included all participants who received 21 days of ENTO (applicable to all groups) and all doses of cytarabine and daunorubicin in Group A Phase 1b, decitabine in Group B Phase 1b, or azacitidine in Group B Phase 2 safety run-in during the DLT assessment window; or experienced a DLT during the DLT assessment window.
DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment. DLT assessment was applicable only for Phase 1b and Phase 2 safety run-in participants.
Outcome measures
| Measure |
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
n=3 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
|
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
n=6 Participants
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m\^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m\^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
|
Group B Phase 1b ENTO 200 mg + Decitabine
n=3 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 1b ENTO 400 mg + Decitabine
n=6 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
n=6 Participants
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b/2 ENTO 400 mg
n=6 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=6 Participants
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b ENTO 400 mg
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)
Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)
Participants R/R AML with mixed-lineage leukemia (MLL) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C3 - Untreated AML)
Participants with previously untreated AML who were unfit for chemotherapy or hypomethylating agents or refused chemotherapy or hypomethylating agent received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At the end of induction (Group A: up to end of Cycle 2; Group B: up to end of Cycle 4) (cycle length = up to 28 days); Group C: From Day 1 until meeting the criteria for study treatment discontinuation (up to approximately 3 years)Population: The Full Analysis Set included all participants who received at least 1 dose of study drug with treatment designated according to the planned treatment.
Clinical response was assessed according to the International Working Group criteria (Cheson 2003). Morphologic CR included CR and cytogenetic CR (CRc). CR required all of the following: \< 5% blasts in bone marrow aspirate; Neutrophils ≥ 1,000/microliter (mcL); Platelets ≥ 100,000/mcL; No extramedullary disease; No blasts with Auer rods detected; and Independent of transfusions. CRc, in addition to CR criteria, required reversion to a normal karyotype with an abnormal karyotype at the time of diagnosis.
Outcome measures
| Measure |
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
n=3 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
|
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
n=9 Participants
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m\^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m\^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
|
Group B Phase 1b ENTO 200 mg + Decitabine
n=41 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 1b ENTO 400 mg + Decitabine
n=5 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
n=6 Participants
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b/2 ENTO 400 mg
n=8 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=17 Participants
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
n=14 Participants
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b ENTO 400 mg
n=7 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=7 Participants
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)
n=6 Participants
Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)
n=13 Participants
Participants R/R AML with mixed-lineage leukemia (MLL) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C3 - Untreated AML)
n=9 Participants
Participants with previously untreated AML who were unfit for chemotherapy or hypomethylating agents or refused chemotherapy or hypomethylating agent received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Morphologic Complete Remission (CR) at the End of Induction
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
46.3 percentage of participants
Interval 30.7 to 62.6
|
0.0 percentage of participants
Interval 0.0 to 52.2
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
0.0 percentage of participants
Interval 0.0 to 19.5
|
7.1 percentage of participants
Interval 0.2 to 33.9
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
15.4 percentage of participants
Interval 1.9 to 45.4
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
PRIMARY outcome
Timeframe: At the end of induction (Group A: up to end of Cycle 2; Group B: up to end of Cycle 4) (cycle length = up to 28 days); Group C: From Day 1 until meeting the criteria for study treatment discontinuation (up to approximately 3 years)Population: Participants in the Full Analysis Set were analyzed.
Clinical response was assessed according to the International Working Group criteria (Cheson 2003). Composite complete remission included CR, CRc, and morphologic complete remission with incomplete blood count recovery (CRi). CR required all of the following: \< 5% blasts in bone marrow aspirate; Neutrophils ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; No extramedullary disease; No blasts with Auer rods detected; and Independent of transfusions. CRc, in addition to CR criteria, required reversion to a normal karyotype with an abnormal karyotype at the time of diagnosis. CRi required all of the CR criteria except the criterion of neutrophils and platelets.
Outcome measures
| Measure |
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
n=3 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
|
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
n=9 Participants
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m\^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m\^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
|
Group B Phase 1b ENTO 200 mg + Decitabine
n=41 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 1b ENTO 400 mg + Decitabine
n=5 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
n=6 Participants
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b/2 ENTO 400 mg
n=8 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=17 Participants
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
n=14 Participants
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b ENTO 400 mg
n=7 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=7 Participants
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)
n=6 Participants
Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)
n=13 Participants
Participants R/R AML with mixed-lineage leukemia (MLL) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C3 - Untreated AML)
n=9 Participants
Participants with previously untreated AML who were unfit for chemotherapy or hypomethylating agents or refused chemotherapy or hypomethylating agent received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Composite Complete Remission at the End of Induction
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
65.9 percentage of participants
Interval 49.4 to 79.9
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
23.5 percentage of participants
Interval 6.8 to 49.9
|
14.3 percentage of participants
Interval 1.8 to 42.8
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
15.4 percentage of participants
Interval 1.9 to 45.4
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
PRIMARY outcome
Timeframe: At the end of induction (Group A: up to end of Cycle 2; Group B: up to end of Cycle 4) (cycle length = up to 28 days); Group C: From Day 1 until meeting the criteria for study treatment discontinuation (up to approximately 3 years)Population: Participants in the Full Analysis Set were analyzed.
Clinical response was assessed according to the International Working Group criteria (Cheson 2003). Overall response included CR, CRc, CRi, and partial remission (PR). CR required all of the following: \< 5% blasts in bone marrow aspirate; Neutrophils ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; No extramedullary disease; No blasts with Auer rods detected; and Independent of transfusions. CRc, in addition to CR criteria, required reversion to a normal karyotype with an abnormal karyotype at the time of diagnosis. CRi required all of the CR criteria except the criterion of neutrophils and platelets. PR required all of the following: ≥ 50% decrease in blasts in bone marrow aspirate to a range of 5% to 25%; Neutrophils ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; Independent of transfusions; and A value of ≤ 5% blasts was also considered a PR if Auer rods were detected.
Outcome measures
| Measure |
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
n=3 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
|
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
n=9 Participants
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m\^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m\^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
|
Group B Phase 1b ENTO 200 mg + Decitabine
n=41 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 1b ENTO 400 mg + Decitabine
n=5 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
n=6 Participants
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b/2 ENTO 400 mg
n=8 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=17 Participants
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
n=14 Participants
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b ENTO 400 mg
n=7 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=7 Participants
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)
n=6 Participants
Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)
n=13 Participants
Participants R/R AML with mixed-lineage leukemia (MLL) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C3 - Untreated AML)
n=9 Participants
Participants with previously untreated AML who were unfit for chemotherapy or hypomethylating agents or refused chemotherapy or hypomethylating agent received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Overall Response at the End of Induction
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
70.7 percentage of participants
Interval 54.5 to 83.9
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
23.5 percentage of participants
Interval 6.8 to 49.9
|
14.3 percentage of participants
Interval 1.8 to 42.8
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
15.4 percentage of participants
Interval 1.9 to 45.4
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
SECONDARY outcome
Timeframe: First dose date up to approximately 3 yearsPopulation: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
n=3 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
|
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
n=50 Participants
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m\^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m\^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
|
Group B Phase 1b ENTO 200 mg + Decitabine
n=5 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 1b ENTO 400 mg + Decitabine
n=6 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
n=8 Participants
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b/2 ENTO 400 mg
n=17 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=14 Participants
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
n=35 Participants
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b ENTO 400 mg
n=7 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)
Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)
Participants R/R AML with mixed-lineage leukemia (MLL) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C3 - Untreated AML)
Participants with previously untreated AML who were unfit for chemotherapy or hypomethylating agents or refused chemotherapy or hypomethylating agent received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Exposure of Entospletinib
|
8.6 weeks
Interval 6.1 to 10.0
|
7.1 weeks
Interval 0.9 to 72.9
|
13.7 weeks
Interval 1.6 to 50.9
|
15.4 weeks
Interval 1.9 to 58.9
|
10.1 weeks
Interval 1.3 to 39.4
|
13.9 weeks
Interval 1.9 to 40.0
|
10.1 weeks
Interval 0.9 to 47.0
|
4.4 weeks
Interval 1.4 to 15.6
|
7.6 weeks
Interval 2.0 to 9.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First dose date up to approximately 38 monthsPopulation: Participants in the Full Analysis Set were analyzed.
EFS was defined as the time interval from the start of the study therapy until the date of treatment failure, acute myeloid leukemia (AML) relapse, or death from any cause, whichever occurred first. Participants who received other anti-cancer therapy (prior to the event if any) were censored. Median EFS was analyzed using Kaplan-Meier (KM) method.
Outcome measures
| Measure |
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
n=3 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
|
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
n=9 Participants
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m\^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m\^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
|
Group B Phase 1b ENTO 200 mg + Decitabine
n=41 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 1b ENTO 400 mg + Decitabine
n=5 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
n=6 Participants
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b/2 ENTO 400 mg
n=8 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=17 Participants
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
n=14 Participants
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b ENTO 400 mg
n=7 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=7 Participants
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)
n=6 Participants
Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)
n=13 Participants
Participants R/R AML with mixed-lineage leukemia (MLL) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C3 - Untreated AML)
n=9 Participants
Participants with previously untreated AML who were unfit for chemotherapy or hypomethylating agents or refused chemotherapy or hypomethylating agent received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Event Free Survival (EFS)
|
NA months
Median and confidence interval limits could not be calculated due to low number of participants with an event.
|
1.9 months
Interval 0.9 to 1.9
|
9.0 months
Interval 2.3 to
Upper limit of confidence interval could not be calculated due to low number of participants with an event.
|
2.2 months
Interval 0.5 to 4.7
|
2.9 months
Interval 1.1 to 7.7
|
2.3 months
Interval 0.5 to 9.0
|
3.2 months
Interval 0.5 to 4.2
|
2.4 months
Interval 2.1 to 3.9
|
1.8 months
Interval 0.9 to 1.9
|
1.8 months
Interval 0.5 to 1.9
|
1.0 months
Interval 0.7 to 2.8
|
1.0 months
Interval 0.8 to 2.7
|
1.7 months
Interval 0.8 to 1.9
|
SECONDARY outcome
Timeframe: First dose date up to approximately 38 monthsPopulation: Participants in the Full Analysis Set were analyzed.
OS was defined as the time interval from the start of the study therapy to death from any cause. Median OS was analyzed using KM method.
Outcome measures
| Measure |
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
n=3 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
|
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
n=9 Participants
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m\^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m\^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
|
Group B Phase 1b ENTO 200 mg + Decitabine
n=41 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 1b ENTO 400 mg + Decitabine
n=5 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
n=6 Participants
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b/2 ENTO 400 mg
n=8 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=17 Participants
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
n=14 Participants
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b ENTO 400 mg
n=7 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=7 Participants
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)
n=6 Participants
Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)
n=13 Participants
Participants R/R AML with mixed-lineage leukemia (MLL) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C3 - Untreated AML)
n=9 Participants
Participants with previously untreated AML who were unfit for chemotherapy or hypomethylating agents or refused chemotherapy or hypomethylating agent received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
37.1 months
Interval 9.1 to
Upper limit of confidence interval could not be calculated due to low number of participants with an event.
|
34.1 months
Interval 1.2 to
Upper limit of confidence interval could not be calculated due to low number of participants with an event.
|
NA months
Interval 16.8 to
Median and upper limit of confidence interval could not be calculated due to low number of participants with an event.
|
3.2 months
Interval 0.8 to 12.7
|
5.3 months
Interval 2.4 to
Upper limit of confidence interval could not be calculated due to low number of participants with an event.
|
6.9 months
Interval 1.4 to
Upper limit of confidence interval could not be calculated due to low number of participants with an event.
|
7.3 months
Interval 2.4 to
Upper limit of confidence interval could not be calculated due to low number of participants with an event.
|
6.2 months
Interval 3.2 to 10.2
|
5.9 months
Interval 0.9 to 6.3
|
5.6 months
Interval 0.5 to 8.4
|
8.2 months
Interval 0.7 to 24.3
|
7.9 months
Interval 3.3 to 11.9
|
2.2 months
Interval 1.0 to 4.7
|
SECONDARY outcome
Timeframe: First dose date up to the last dose date plus 30 days (maximum: 18 months)Population: Participants in the Safety Analysis Set were analyzed.
Outcome measures
| Measure |
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
n=3 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
|
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
n=50 Participants
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m\^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m\^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
|
Group B Phase 1b ENTO 200 mg + Decitabine
n=5 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 1b ENTO 400 mg + Decitabine
n=6 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
n=8 Participants
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b/2 ENTO 400 mg
n=17 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=14 Participants
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
n=35 Participants
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b ENTO 400 mg
n=7 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)
Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)
Participants R/R AML with mixed-lineage leukemia (MLL) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C3 - Untreated AML)
Participants with previously untreated AML who were unfit for chemotherapy or hypomethylating agents or refused chemotherapy or hypomethylating agent received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First dose date up to the last dose date plus 30 days (maximum: 18 months)Population: Participants in the Safety Analysis Set who had non-missing postbaseline value prior to or on the last dosing date plus 30 days were analyzed.
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.
Outcome measures
| Measure |
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
n=3 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
|
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
n=50 Participants
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m\^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m\^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
|
Group B Phase 1b ENTO 200 mg + Decitabine
n=5 Participants
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 1b ENTO 400 mg + Decitabine
n=6 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
n=7 Participants
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b/2 ENTO 400 mg
n=17 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=14 Participants
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
n=35 Participants
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b ENTO 400 mg
n=7 Participants
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C1A - R/R AML)
Participants with relapsed/refractory (R/R) acute myeloid leukemia (AML) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C2 - MLL)
Participants R/R AML with mixed-lineage leukemia (MLL) received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 2 ENTO 400 mg (Cohort C3 - Untreated AML)
Participants with previously untreated AML who were unfit for chemotherapy or hypomethylating agents or refused chemotherapy or hypomethylating agent received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced Laboratory Abnormalities
Any Laboratory Abnormality
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
94.1 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Experienced Laboratory Abnormalities
Grade 3 or 4 Laboratory Abnormalities
|
100 percentage of participants
|
98.0 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
85.7 percentage of participants
|
94.1 percentage of participants
|
92.9 percentage of participants
|
82.9 percentage of participants
|
85.7 percentage of participants
|
—
|
—
|
—
|
—
|
Adverse Events
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
Serious events: 23 serious events
Other events: 50 other events
Deaths: 21 deaths
Group B Phase 1b ENTO 200 mg + Decitabine
Serious events: 5 serious events
Other events: 5 other events
Deaths: 5 deaths
Group B Phase 1b ENTO 400 mg + Decitabine
Serious events: 5 serious events
Other events: 6 other events
Deaths: 4 deaths
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
Serious events: 7 serious events
Other events: 7 other events
Deaths: 5 deaths
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
Serious events: 11 serious events
Other events: 17 other events
Deaths: 12 deaths
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
Serious events: 7 serious events
Other events: 14 other events
Deaths: 11 deaths
Group C Phase 1b/2 ENTO 400 mg
Serious events: 19 serious events
Other events: 33 other events
Deaths: 30 deaths
Group C Phase 1b ENTO 800 mg
Serious events: 4 serious events
Other events: 7 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
n=3 participants at risk
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
|
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
n=50 participants at risk
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m\^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m\^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
|
Group B Phase 1b ENTO 200 mg + Decitabine
n=5 participants at risk
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 1b ENTO 400 mg + Decitabine
n=6 participants at risk
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
n=8 participants at risk
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
n=17 participants at risk
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
n=14 participants at risk
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b/2 ENTO 400 mg
n=35 participants at risk
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=7 participants at risk
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
26.0%
13/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
80.0%
4/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
4/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
37.5%
3/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
47.1%
8/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
5/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Otitis media
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Troponin I increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuromyopathy
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Group A Phase 1b ENTO 200 mg + Cytarabine + Daunorubicin
n=3 participants at risk
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (during induction chemotherapy).
|
Group A Phase 1b/2 ENTO 400 mg + Cytarabine + Daunorubicin
n=50 participants at risk
Phase1b/2: Participants received ENTO 400 mg tablet orally every 12 hours on Days 1 to 14 (Cycle 0) (monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with chemotherapy (cytarabine 100 mg/m\^2 on Days 1-7 and daunorubicin 60 mg/m\^2 on Days 1-3 intravenously) for up to two 14-day cycles (Cycles 1 and 2) (induction chemotherapy).
Phase 2 only: Participants who achieved a CR/CRi and did not require or could not proceed to allogeneic stem cell transplantation (SCT) were offered post-remission chemotherapy (cytarabine 3 g/m\^2 intravenously every 12 hours on Days 1, 3, and 5 or 1 g/m\^2 intravenously once daily on Days 1-5) in combination with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for at least 3 and up to 4 cycles. Participants who maintained a CR/CRi after 3 or 4 cycles were offered maintenance therapy with ENTO 400 mg tablet orally every 12 hours on Days 1-28 of each 28-day cycle for up to 12 cycles.
|
Group B Phase 1b ENTO 200 mg + Decitabine
n=5 participants at risk
Participants received ENTO 200 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 200 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 200 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 1b ENTO 400 mg + Decitabine
n=6 participants at risk
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28) (induction chemotherapy). Participants who achieved a CR/CRi received SCT (if eligible) per investigator's discretion; other participants were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Safety Run-In)
n=8 participants at risk
As part of the safety run-in, participants received ENTO 400 mg tablet orally every 12 hours on Days 1-14 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of a 28-day cycle (Cycle 1). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Decitabine (Randomized)
n=17 participants at risk
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with decitabine 20 mg/m\^2 intravenously on Days 1-10 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with decitabine on Days 1-5 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to decitabine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group B Phase 2 ENTO 400 mg + Azacitidine (Randomized)
n=14 participants at risk
Participants were randomized to receive ENTO 400 mg tablet orally every 12 hours on Days 1-5 (Cycle 0) (during monotherapy lead-in), followed by ENTO 400 mg tablet orally every 12 hours in combination with azacitidine 75 mg/m\^2 intravenously on Days 1-7 of every 28-day cycle for 2 cycles (or up to 4 cycles for participants with persistent disease after Cycle 2 Day 28). Participants who were not eligible for SCT were offered maintenance therapy with ENTO every 12 hours on Days 1-28 in combination with azacitidine on Days 1-7 of every 28-day cycle for at least 2 cycles (maximum up to 12 cycles). Participants who were intolerant to azacitidine were offered maintenance therapy with ENTO 400 mg as monotherapy after completing 2 maintenance cycles.
|
Group C Phase 1b/2 ENTO 400 mg
n=35 participants at risk
Participants received ENTO 400 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
Group C Phase 1b ENTO 800 mg
n=7 participants at risk
Participants received ENTO 800 mg tablet orally every 12 hours on Days 1-28 of every 28-day cycle until treatment failure, start of new therapy, unacceptable toxicity, withdrawal of consent, withdrawal from study by investigator, or study termination by sponsor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.0%
8/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
3/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.6%
3/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
24.0%
12/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
29.4%
5/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
4/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
3/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.0%
6/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
7/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Body temperature increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Chest X-ray abnormal
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
5/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.0%
4/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
International normalised ratio increased
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
23.5%
4/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
32.0%
16/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
23.5%
4/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.1%
6/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
52.0%
26/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
60.0%
3/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
3/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
37.5%
3/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
29.4%
5/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
7/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.7%
9/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Spleen palpable
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Troponin I increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Troponin increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Ultrasound liver abnormal
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.6%
3/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Weight increased
|
66.7%
2/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
36.0%
18/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
41.2%
7/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
35.7%
5/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.4%
4/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
44.0%
22/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
37.5%
3/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
35.3%
6/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
6/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
7/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.0%
4/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
35.7%
5/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
4/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
21.4%
3/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.6%
3/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
21.4%
3/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.6%
3/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
10/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.6%
3/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
21.4%
3/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.4%
4/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.0%
7/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
4/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
3/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.0%
4/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
23.5%
4/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
35.7%
5/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.6%
3/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.4%
4/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.0%
7/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.0%
6/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.1%
6/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.0%
4/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.6%
3/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.0%
6/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.4%
4/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
23.5%
4/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
3/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Vertebral lesion
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.0%
14/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
5/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
22.0%
11/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
37.5%
3/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
21.4%
3/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
20/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
3/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.6%
3/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.1%
6/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.0%
4/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
3/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.0%
7/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
3/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Apathy
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
5/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
5/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Hallucination
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
32.0%
16/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
4/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
7/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.0%
8/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
21.4%
3/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
3/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
5/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.0%
4/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
36.0%
18/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
4/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
37.5%
3/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
29.4%
5/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
35.7%
5/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
5/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
20/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
3/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
29.4%
5/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
4/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
10/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
10/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.6%
3/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
7/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
22.0%
11/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.0%
7/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
10/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.6%
3/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hyposecretion
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.0%
4/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.6%
3/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
3/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.0%
6/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.0%
4/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.0%
7/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.0%
21/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
3/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
22.9%
8/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
5/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
24.0%
12/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
3/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.6%
3/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.0%
7/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
23.5%
4/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
35.7%
5/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.1%
6/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
48.0%
24/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
60.0%
3/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
29.4%
5/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
6/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
10/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
3/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
66.7%
2/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
72.0%
36/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
3/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
4/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
22.9%
8/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.0%
7/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.6%
3/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
21.4%
3/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
5/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.0%
6/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Dry eye
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.0%
4/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye oedema
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Optic nerve cupping
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Scleral hyperaemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
10/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.0%
7/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
26.0%
13/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
4/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.4%
4/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
23.5%
4/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Angina bullosa haemorrhagica
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
20/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
60.0%
3/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
4/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
75.0%
6/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
58.8%
10/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
64.3%
9/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
3/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
68.0%
34/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
3/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
37.5%
3/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
52.9%
9/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
4/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
14/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
57.1%
4/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.0%
8/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Enterocolitis
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.0%
6/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
5/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.6%
3/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
3/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal dilatation
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
68.0%
34/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
80.0%
4/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
66.7%
4/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
4/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
29.4%
5/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
7/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
15/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
5/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
21.4%
3/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.0%
8/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
23.5%
4/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.1%
6/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
32.0%
16/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
35.3%
6/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
35.7%
5/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
22.9%
8/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter site dermatitis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter site erythema
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter site rash
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.0%
8/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
35.7%
5/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.4%
4/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Device related thrombosis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Face oedema
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.0%
14/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
60.0%
3/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
52.9%
9/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
6/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
10/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
3/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Feeling hot
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site erythema
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site pain
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
10/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.4%
4/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.0%
7/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
66.7%
2/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
58.0%
29/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
40.0%
2/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
3/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
50.0%
4/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
35.3%
6/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
4/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.4%
4/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
42.9%
3/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Performance status decreased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
18.0%
9/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
5/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.0%
4/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Device related infection
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
18.0%
9/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Leptotrichia infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
22.0%
11/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
33.3%
2/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
3/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.0%
3/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.0%
5/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
3/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.5%
1/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.7%
2/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.0%
4/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.7%
1/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
37.5%
3/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
21.4%
3/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.6%
3/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
20.0%
1/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.4%
4/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
1/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.8%
2/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.0%
6/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
23.5%
4/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.0%
2/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.0%
1/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.9%
1/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
1/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
33.3%
1/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.3%
2/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.0%
8/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
25.0%
2/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
1/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.4%
4/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
2/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/50 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/5 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/6 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/8 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/17 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
28.6%
4/14 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/35 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/7 • - All-Cause Mortality: First dose date up to approximately 38 months. - Adverse Events: First dose date up to the last dose date plus 30 days (maximum: 18 months)
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER