Trial Outcomes & Findings for Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NCT NCT02953509)
NCT ID: NCT02953509
Last Updated: 2025-05-29
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 in participant in Phase 1b. A DLT was defined as any Grade 3 or greater AE that was assessed as related to either magrolimab and/or rituximab that occurred during the 4-week DLT observation period. Any treatment-emergent adverse event (TEAE) that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
178 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2025-05-29
Participant Flow
Participants were enrolled at study sites in Australia, the United Kingdom, and the United States.
209 participants were screened.
Participant milestones
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
Participants with B-cell non-hodgkin's lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11,15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
Autologous stem cell transplant (or transplantation) ineligible diffuse large B-cell lymphoma (DLBCL) participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. Granulocyte colony stimulating factor (G-CSF) prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
13
|
7
|
26
|
7
|
43
|
14
|
31
|
28
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
13
|
7
|
26
|
7
|
43
|
14
|
31
|
28
|
Reasons for withdrawal
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
Participants with B-cell non-hodgkin's lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11,15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
Autologous stem cell transplant (or transplantation) ineligible diffuse large B-cell lymphoma (DLBCL) participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. Granulocyte colony stimulating factor (G-CSF) prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
3
|
3
|
4
|
12
|
3
|
25
|
10
|
21
|
20
|
|
Overall Study
Reason Not Specified
|
0
|
2
|
8
|
2
|
11
|
4
|
12
|
2
|
7
|
2
|
|
Overall Study
Consent Withdrawn
|
1
|
1
|
2
|
1
|
3
|
0
|
4
|
1
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
|
Overall Study
Study terminated by sponsor
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
Baseline Characteristics
Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
n=3 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
n=6 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
n=13 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11,15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
n=7 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=26 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=7 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 11, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
n=43 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
n=14 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
n=31 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 11, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
n=28 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
Total~(N=178)
n=178 Participants
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
70 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
108 Participants
n=42 Participants
|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
60 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
61 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
63 years
STANDARD_DEVIATION 15.2 • n=4 Participants
|
65 years
STANDARD_DEVIATION 14.4 • n=21 Participants
|
70 years
STANDARD_DEVIATION 9.5 • n=8 Participants
|
62 years
STANDARD_DEVIATION 13.2 • n=8 Participants
|
71 years
STANDARD_DEVIATION 6.7 • n=24 Participants
|
70 years
STANDARD_DEVIATION 11.5 • n=42 Participants
|
70 years
STANDARD_DEVIATION 12.4 • n=42 Participants
|
66 years
STANDARD_DEVIATION 12.7 • n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
67 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
111 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
28 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
162 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
28 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
154 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
28 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
162 Participants
n=42 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: The DLT Analysis Set 1 (Antibody Combination) included all enrolled Phase 1b participants in the magrolimab + rituximab cohort who met either of the following criteria: * The participant experienced a DLT * The participants completed at least 3 infusions of magrolimab and 2 infusions of rituximab.
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 in participant in Phase 1b. A DLT was defined as any Grade 3 or greater AE that was assessed as related to either magrolimab and/or rituximab that occurred during the 4-week DLT observation period. Any treatment-emergent adverse event (TEAE) that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
n=3 Participants
Participants with B-cell Non-Hodgkin's Lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
n=6 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
n=13 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
n=6 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + Rituximab
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Antibody Treatment Combination
|
0 percentage of participants
|
16.7 percentage of participants
|
15.4 percentage of participants
|
16.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: The DLT Analysis Set 2 (Chemotherapy Combination)included all enrolled Phase 1b participants in the magrolimab + rituximab, gemcitabine,and oxaliplatin (R-GemOx) cohort who met either of the following criteria in DLT assessment period: * Participants had DLT at any time after initiation of first infusion of magrolimab, rituximab, and gemcitabine or oxaliplatin * Participants completed at least 3 infusions of magrolimab, 2 infusions of rituximab, and 1 infusion of gemcitabine and oxaliplatin
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 in participant in Phase 1b. DLT was defined as any Grade 3 or greater AE including Grade 4 hematologic toxicity that does not resolve to Grade 2 and delays initiation of cycle 2 by more than 14 days, Grade 4 febrile neutropenia or associated infections, Grade 4 non-hematologic toxicity that does not resolve or decrease to Grade 2 within 1 week, Grade 4 infusion-related reaction (IRR), and recurrent Grade 3 or greater IRR despite optimal pretreatment regimen that was assessed as related to either magrolimab, rituximab, gemcitabine, or oxaliplatin and occurred during the 4-week DLT observation period. Any TEAE that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
n=5 Participants
Participants with B-cell Non-Hodgkin's Lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
n=6 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + Rituximab
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) in Chemotherapy Treatment Combination
|
0 percentage of participants
|
16.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 7.2 yearsPopulation: The Safety Analysis Set included all participants who received at least 1 dose of any study treatment.
TEAE's were defined as any AEs with an onset date on or after the study drug start date, no later than 30 days after last dose of any study drug or day before initiation of subsequent line of anti-cancer therapy, whichever is earlier, or the AEs leading to the discontinuation of the study drug. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product or other protocol imposed intervention, regardless of attribution.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
n=3 Participants
Participants with B-cell Non-Hodgkin's Lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
n=6 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
n=13 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
n=7 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=26 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=7 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
n=43 Participants
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
n=14 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
n=31 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
n=28 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + Rituximab
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
96.2 percentage of participants
|
100.0 percentage of participants
|
97.7 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 7.3 yearsPopulation: The Efficacy Analysis Set included all enrolled participants who received at least 1 dose of magrolimab. As prespecified in the statistical analysis plan (SAP), the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).
ORR:CR(complete metabolic response(CMR);complete radiological response(CRR)) or PR(partial metabolic response(PMR);partial radiologic response(PRR)).CMR:PET 5 point-scale(5PS) with 1(no uptake above background,2(uptake≤mediastinum),3(uptake\>mediastinum but≤liver)with/without residual mass;no new lesions;no fluorodeoxyglucose (FDG)-avid disease in bone marrow(BM).CRR:target nodes/nodal masses regressed ≤1.5cm in longest transverse diameter of lesion(LDi);no extra lymphatic disease sites;absent non-measured lesions(NMLs);organ enlargement to normal;no new sites;BM morphology normal.PMR:scores 4(uptake moderately\>liver),5(uptake markedly\>liver,new lesions)with reduced uptake from baseline \& residual mass;no new lesion;responding disease at interim/residual disease at end of treatment.PRR:≥50% decrease in sum of perpendicular diameters up to 6 target measurable nodes,extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed \>50% length beyond normal; no new sites.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
n=2 Participants
Participants with B-cell Non-Hodgkin's Lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
n=1 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
n=6 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=68 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=30 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
n=23 Participants
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
n=15 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
n=26 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
n=7 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + Rituximab
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) as Defined by the Investigator According to the Lugano Classification for Lymphomas
|
0 percentage of participants
Interval 0.0 to 84.2
|
0 percentage of participants
Interval 0.0 to 97.5
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
—
|
20.6 percentage of participants
Interval 11.7 to 32.1
|
60.0 percentage of participants
Interval 40.6 to 77.3
|
26.1 percentage of participants
Interval 10.2 to 48.4
|
33.3 percentage of participants
Interval 11.8 to 61.6
|
46.2 percentage of participants
Interval 26.6 to 66.6
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)Population: The Pharmacokinetics (PK) Analysis Set included all participants who received at least 1 dose of study drug and had measurable concentrations of magrolimab from PK blood samples. Participants in the PK Analysis Set with available data were analyzed. The PK data was reported for Phase 2 (antibody combination) as per maintenance dose level and disease type.
AUClast is defined as the concentration of drug from time zero to the last observable concentration. N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
n=3 Participants
Participants with B-cell Non-Hodgkin's Lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
n=5 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
n=14 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
n=8 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=18 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=7 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
n=18 Participants
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
n=24 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
n=14 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
n=2 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
n=15 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
n=12 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + Rituximab
n=1 Participants
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
n=8 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter of Magrolimab: AUClast
Day 1 (Cycle 1, Day 1)
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
—
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
—
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
—
|
—
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
|
PK Parameter of Magrolimab: AUClast
Day 8 (Cycle 1, Day 8)
|
770 day*micrograms(μg)/milliliters(mL)
Standard Deviation 346
|
1810 day*micrograms(μg)/milliliters(mL)
Standard Deviation 426
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
2300 day*micrograms(μg)/milliliters(mL)
Standard Deviation 280
|
2220 day*micrograms(μg)/milliliters(mL)
Standard Deviation 877
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
|
PK Parameter of Magrolimab: AUClast
Day 29 (Cycle 2, Day 1)
|
1470 day*micrograms(μg)/milliliters(mL)
Standard Deviation 431
|
4260 day*micrograms(μg)/milliliters(mL)
Standard Deviation 1050
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*micrograms(μg)/milliliters(mL)
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
SECONDARY outcome
Timeframe: Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)Population: Participants in the PK Analysis Set with available data were analyzed. The PK data was reported for Phase 2 (antibody combination) as per maintenance dose level and disease type.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
n=3 Participants
Participants with B-cell Non-Hodgkin's Lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
n=5 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
n=14 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
n=8 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=18 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=7 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
n=18 Participants
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
n=24 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
n=14 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
n=2 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
n=15 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
n=12 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + Rituximab
n=1 Participants
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
n=8 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter of Magrolimab: AUCtau
Day 1 (Cycle 1, Day 1)
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
—
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
—
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
—
|
—
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
|
PK Parameter of Magrolimab: AUCtau
Day 8 (Cycle 1, Day 8)
|
671 day*μg/mL
Standard Deviation NA
Standard deviation cannot be calculated for 1 participant.
|
1810 day*μg/mL
Standard Deviation 426
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
2300 day*μg/mL
Standard Deviation 280
|
2080 day*μg/mL
Standard Deviation 658
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
|
PK Parameter of Magrolimab: AUCtau
Day 29 (Cycle 2, Day 1)
|
1220 day*μg/mL
Standard Deviation 97.0
|
4260 day*μg/mL
Standard Deviation 1050
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA day*μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
SECONDARY outcome
Timeframe: Phase 1: Pre-dose (12 hours) and 1 and 24 hours post-dose on Day 1 (Cycle 1 Day 1 [C1D1]); pre-dose and 1, 24, and 72 hours post-dose on Day 8 (C1D8) and Day 29 (C2D1); Phase 2 :Pre-dose (12 hours) on Days 1 (C1D1), 8 (C1D8), and 29 (C2D1)Population: Participants in the PK Analysis Set with available data were analyzed. The PK data was reported for Phase 2 (antibody combination) as per maintenance dose level and disease type.
Cmax is defined as the maximum observed concentration of drug. N = 0 participants for Phase 1b Cohorts 4 and 6, Phase 2 Cohort 3 (DLBCL and iNHL), since PK samples were not collected for Day 1.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
n=3 Participants
Participants with B-cell Non-Hodgkin's Lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
n=5 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
n=14 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
n=8 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=18 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=7 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
n=18 Participants
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
n=24 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
n=14 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
n=2 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
n=15 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
n=12 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + Rituximab
n=1 Participants
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
n=8 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameter of Magrolimab: Cmax
Day 1 (Cycle 1, Day 1)
|
0.619 μg/mL
Standard Deviation NA
Standard deviation cannot be calculated for 1 participant.
|
1.32 μg/mL
Standard Deviation 1.31
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
—
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
—
|
0.477 μg/mL
Standard Deviation 0.178
|
0.496 μg/mL
Standard Deviation 0.353
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
—
|
—
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
|
PK Parameter of Magrolimab: Cmax
Day 8 (Cycle 1, Day 8)
|
212 μg/mL
Standard Deviation 54.6
|
485 μg/mL
Standard Deviation 114
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
924 μg/mL
Standard Deviation 170
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
906 μg/mL
Standard Deviation 160
|
567 μg/mL
Standard Deviation 75.7
|
542 μg/mL
Standard Deviation 188
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
918 μg/mL
Standard Deviation 251
|
904 μg/mL
Standard Deviation 414
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
|
PK Parameter of Magrolimab: Cmax
Day 29 (Cycle 2, Day 1)
|
330 μg/mL
Standard Deviation 123
|
903 μg/mL
Standard Deviation 186
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
1862 μg/mL
Standard Deviation 411
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
2096 μg/mL
Standard Deviation 449
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
1858 μg/mL
Standard Deviation 321
|
2186 μg/mL
Standard Deviation 615
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
NA μg/mL
Standard Deviation NA
Data could not be calculated due to multiple concentration values below the level of detection; at least 3 \[or 4\] quantifiable data points were required.
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: The ADA analysis set included participants with at least one reported ADA result where participants evaluable for ADA incidence were defined as participants with non-missing baseline sample and at least one sample taken after drug administration during the treatment or follow-up observation period that are appropriate for ADA testing (with reportable result). As prespecified in SAP,ADA results were to be reported for Phase 2 (antibody combination) as per maintenance dose level and disease type.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
n=3 Participants
Participants with B-cell Non-Hodgkin's Lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
n=6 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
n=14 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
n=7 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=15 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=6 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
n=17 Participants
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
n=24 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
n=13 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
n=2 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
n=11 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
n=3 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + Rituximab
n=1 Participants
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
n=3 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Developed Anti-Magrolimab Antibodies (ADA)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
6.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
7.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 7.3 yearsPopulation: Participants in the Efficacy Analysis Set with an objective response (CR + PR) and those who had objective response without a subsequent event of disease progression/death were analyzed. As prespecified in the SAP, the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).
DOR is measured from when first OR is met(CR or PR)until the first date of documented progressive disease\[progressive metabolic disease(PMD);progressive radiologic disease(PRD)\]while on study prior to start of next line anti-cancer therapy.Participants with no progressive disease were censored at last response assessment date.Response assessment post start of anti-cancer therapy was excluded from derivation.OR defined in outcome measure 4.PMD:scores 4(uptake moderately\>liver),5(uptake markedly\>liver,new lesions)with increased uptake from baseline;new FDG-avid foci consistent with lymphoma rather than another etiology;new or recurrent FDG-avid foci in BM.PRD:LDi \>1.5 cm;≥ 50% increase from cross product of LDi \& perpendicular diameter(PPD);increase in LDi or shortest axis perpendicular to LDi(SDi) of 0.5 cm for lesions ≤ 2 \& 1 cm for lesions \>2 cm;spleen increased by \>50% in length beyond normal;new or recurrent splenomegaly,BM involved;new lesions;progression of pre-existing lesions.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
Participants with B-cell Non-Hodgkin's Lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
n=1 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
n=3 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=14 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=18 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
n=6 Participants
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
n=5 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
n=12 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
n=5 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + Rituximab
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
—
|
NA months
The median, lower, and upper limit of 95% confidence interval (CI) were not estimable due to insufficient number of events.
|
NA months
Interval 3.9 to
The median and upper limit of 95% CI were not estimable due to insufficient number of events.
|
—
|
5.5 months
Interval 3.5 to 22.3
|
15.9 months
Interval 5.6 to
The upper limit of 95% CI was not estimable due to insufficient number of events.
|
21.2 months
Interval 1.8 to
The upper limit of 95% CI was not estimable due to insufficient number of events.
|
11.3 months
Interval 3.5 to
The upper limit of 95% CI was not estimable due to insufficient number of events.
|
NA months
Interval 2.0 to
The median and upper limit of 95% CI were not estimable due to insufficient number of events.
|
18.0 months
Interval 4.7 to
The upper limit of 95% CI were not estimable due to insufficient number of events.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 7.3 yearsPopulation: Participants in the efficacy analysis set with available data were analyzed. As prespecified in the SAP, the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).
PFS is measured from dose initiation until the first date of objectively documented disease progression (PMD; PRD) or death while on study prior to start of the subsequent line of anti-cancer therapy. Participants who do not have progressive disease \& not died were censored at last response assessment date.Response assessments after initiation of the subsequent line of anti-cancer therapy will be excluded from derivation. PMD: scores 4 (uptake moderately \> liver), 5 (uptake markedly \> liver, new lesions) with increased uptake from baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in BM. PRD: LDi \>1.5 cm; ≥ 50% increase from cross product of LDi \& PPD; increase in LDi or SDi of 0.5 cm for lesions ≤ 2 \& 1 cm for lesions \>2 cm; spleen increased by \>50% in length beyond normal; new or recurrent splenomegaly, BM involvement; new lesions; progression of pre-existing lesions. KM estimates of median was reported.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
n=2 Participants
Participants with B-cell Non-Hodgkin's Lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
n=1 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
n=6 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=68 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=30 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
n=23 Participants
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
n=15 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
n=26 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
n=7 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + Rituximab
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
1.6 months
Interval 1.4 to
The upper limit of 95% CI was not estimable due to insufficient number of events.
|
NA months
The median, lower, and upper limit of 95% CI was not estimable due to insufficient number of events.
|
5.6 months
Interval 1.2 to
The upper limit of 95% CI was not estimable due to insufficient number of events.
|
—
|
1.8 months
Interval 1.6 to 2.1
|
7.5 months
Interval 5.5 to 23.9
|
2.1 months
Interval 1.6 to 3.6
|
5.5 months
Interval 1.8 to 13.0
|
3.9 months
Interval 2.3 to 11.1
|
20.3 months
Interval 0.5 to
The upper limit of 95% CI was not estimable due to insufficient number of events.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 7.3 yearsPopulation: Participants in the Efficacy Analysis Set with available were analyzed. As prespecified in the SAP, the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).
OS is measured from dose initiation until death.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
n=2 Participants
Participants with B-cell Non-Hodgkin's Lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
n=1 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
n=6 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=68 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=30 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
n=23 Participants
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
n=15 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
n=26 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
n=7 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + Rituximab
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
13.9 months
The lower and upper limit of 95% CI were not estimable due to insufficient number of events.
|
NA months
The median, lower and upper limit of 9,5% CI were not estimable due to insufficient number of events.
|
32.2 months
Interval 2.3 to
The upper-limit of 95% CI were not estimable due to insufficient number of events.
|
—
|
8.5 months
Interval 5.8 to 11.3
|
NA months
Interval 62.9 to
The median and upper-limit of 95% CI were not estimable due to insufficient number of events.
|
14.0 months
Interval 3.4 to 17.4
|
23.7 months
Interval 3.8 to
The upper-limit of 95% CI were not estimable due to insufficient number of events.
|
41.4 months
Interval 6.1 to
The upper-limit of 95% CI were not estimable due to insufficient number of events.
|
NA months
Interval 0.5 to
The median and upper-limit of 95% CI were not estimable due to insufficient number of events.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 7.3 yearsPopulation: Participants in the Efficacy Analysis Set with available data were analyzed. As prespecified in the SAP, the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).
TTP is measured from dose initiation until the first date of objectively documented progressive disease criteria while on study prior to start of next line anti-cancer therapy. Participants with no progressive disease were censored at last response assessment date. Response assessment post start of anti-cancer therapy was excluded from derivation. PMD: scores 4 (uptake moderately \> liver), 5 (uptake markedly \> liver, new lesions) with increased uptake compared with baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi \>1.5 cm; = 50% increase from cross product of LDi and PPD; increase in LDi or SDi of 0.5 cm for lesions =1.5 cm and 1 cm for lesions \>2 cm; spleen increased by \>50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. Kaplan-meier (KM) estimates of median was reported.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
n=2 Participants
Participants with B-cell Non-Hodgkin's Lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
n=1 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
n=6 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=68 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=30 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
n=23 Participants
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
n=15 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
n=26 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
n=7 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + Rituximab
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Progression (TTP)
|
1.6 months
Interval 1.4 to
The upper limit of 95% CI was not estimable due to insufficient number of events.
|
NA months
The median, lower, and upper limit of 95% CI was not estimable due to insufficient number of events.
|
5.6 months
Interval 1.2 to
The upper limit of 95% CI was not estimable due to insufficient number of events.
|
—
|
1.8 months
Interval 1.7 to 2.1
|
7.9 months
Interval 5.5 to 23.9
|
2.0 months
Interval 1.6 to 4.3
|
5.6 months
Interval 1.8 to 13.0
|
3.9 months
Interval 2.3 to
The upper limit of 95% CI was not estimable due to insufficient number of events.
|
20.3 months
Interval 6.6 to
The upper limit of 95% CI was not estimable due to insufficient number of events.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 7.3 yearsPopulation: Participants in the Efficacy Analysis Set with available data were analyzed. As prespecified in the SAP, the efficacy results were to be reported for Phase 1b and 2 combined per dose and disease type (for both antibody and chemotherapy combinations).
Objective response is defined as complete response or partial response determined by LYRIC criteria. ORR:CR\[CMR;CRR\] or PR\[PMR;PRR\].CMR:PET 5 PS with 1(no uptake above background,2(uptake≤mediastinum),3(uptake\>mediastinum but≤liver)with/without residual mass;no new lesions;no FDG-avid disease in BM.CRR:target nodes/nodal masses regressed to ≤1.5cm in LDi;no extralymphatic disease sites;absent NMLs;organ enlargement to normal;no new sites;BM morphology normal.PMR:scores 4(uptake moderately\>liver),5(uptake markedly\>liver,new lesions)with reduced uptake from baseline and residual mass;no new lesion;responding disease at interim/residual disease at end of treatment.PRR: ≥50% decrease in sum of product of perpendicular diameters up to 6 target measurable nodes,extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed \>50% in length beyond normal;no new sites.
Outcome measures
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
n=2 Participants
Participants with B-cell Non-Hodgkin's Lymphoma (NHL) received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
n=1 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
n=6 Participants
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=68 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=30 Participants
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
n=23 Participants
Participants with B-cell indolent NHL (iNHL) (including follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
n=15 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
n=26 Participants
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
n=7 Participants
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
Phase 2 Cohort 3 (DLBCL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 45 mg/kg (Loading Dose) + Rituximab
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 3 (iNHL): Magrolimab 20 mg/kg (Loading Dose) + Rituximab
Participants in this group had magrolimab maintenance dose de-escalated from 45 to 20 mg/kg with the identical dosing schedule of maintenance doses by the Clinical Trial Steering Committee (CTSC). Participants with B-cell iNHL (including FL and MZL) received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 20 mg/kg on Day 11 of Cycle 1.Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
Phase 2 Cohort 4: Magrolimab 30 mg/ kg (No Loading Dose) + Rituximab
Participants with DLBCL received 1 mg/kg magrolimab IV infusion of priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, followed by Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and subsequent cycles, rituximab was administered on Day 1 of every other cycle (on even cycles). Cycle length was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
ORR (CR + PR) Defined by the Investigator According to the Lymphoma Response to Immunomodulatory Therapy Criteria for Lymphomas
|
0 percentage of participants
Interval 0.0 to 84.2
|
0 percentage of participants
Interval 0.0 to 97.5
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
—
|
22.1 percentage of participants
Interval 12.9 to 33.8
|
60.0 percentage of participants
Interval 40.6 to 77.3
|
26.1 percentage of participants
Interval 10.2 to 48.4
|
33.3 percentage of participants
Interval 11.8 to 61.6
|
46.2 percentage of participants
Interval 26.6 to 66.6
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
Serious events: 2 serious events
Other events: 6 other events
Deaths: 4 deaths
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
Serious events: 6 serious events
Other events: 13 other events
Deaths: 5 deaths
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
Serious events: 1 serious events
Other events: 7 other events
Deaths: 4 deaths
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
Serious events: 21 serious events
Other events: 25 other events
Deaths: 12 deaths
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
Serious events: 5 serious events
Other events: 7 other events
Deaths: 3 deaths
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
Serious events: 19 serious events
Other events: 42 other events
Deaths: 26 deaths
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
Serious events: 9 serious events
Other events: 14 other events
Deaths: 10 deaths
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
Serious events: 21 serious events
Other events: 31 other events
Deaths: 22 deaths
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
Serious events: 11 serious events
Other events: 27 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
n=3 participants at risk
Participants with B-cell NHL received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
n=6 participants at risk
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
n=13 participants at risk
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
n=7 participants at risk
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=26 participants at risk
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=7 participants at risk
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
n=43 participants at risk
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
n=14 participants at risk
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
n=31 participants at risk
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
n=28 participants at risk
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
9.3%
4/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Malignant ascites
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Retroperitoneal mass
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Death, not otherwise specified
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Disease progression
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
11.5%
3/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Covid-19
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
3/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
2/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
4/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
2/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.1%
5/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
10.7%
3/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Chest wall haematoma
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Product Issues
Device dislocation
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
2/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
9.7%
3/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
33.3%
2/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
Other adverse events
| Measure |
Phase 1b Cohort 1: Magrolimab 10 mg/kg + Rituximab
n=3 participants at risk
Participants with B-cell NHL received 1 mg/kg magrolimab intravenous (IV) infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 10 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 86.6 months.
|
Phase 1b Cohort 2: Magrolimab 20 mg/kg + Rituximab
n=6 participants at risk
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 20 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 83.3 months.
|
Phase 1b Cohort 3: Magrolimab 30 mg/kg + Rituximab
n=13 participants at risk
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 67.9 months.
|
Phase 1b Cohort 4: Magrolimab 45 mg/kg + Rituximab
n=7 participants at risk
Participants with B-cell NHL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1 and Days 1, 8, 15, and 22 of Cycle 2 and beyond in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 29.2 months.
|
Phase 1b Cohort 5: Magrolimab 30 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=26 participants at risk
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 30 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 23.2 months.
|
Phase 1b Cohort 6: Magrolimab 45 mg/kg + Rituximab + Gemcitabine + Oxaliplatin
n=7 participants at risk
Autologous stem cell transplant (or transplantation) ineligible DLBCL participants received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by maintenance dose of 45 mg/kg on Days 8, 15, 22, and 29 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 followed by Days 1 and 15 of subsequent cycles. The cycle length was 28 days. Rituximab 375 mg/m\^2 IV infusion was administered on Days 8, 15, 22, and 29 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Gemcitabine 1000 mg/m\^2 and oxaliplatin 100 mg/m\^2 IV infusion were administered as on Days 11 and 23 of Cycle 1 and Days 2 and 15 of Cycles 2 to 4. G-CSF prophylaxis was administered with gemcitabine and oxaliplatin treatment (Cycles 1-4). Allopurinol 300 mg orally daily was administered for the first cycle only.
The maximum duration of treatment was up to approximately 10.8 months.
|
Phase 2 Cohort 1: Magrolimab 30 mg/kg + Rituximab
n=43 participants at risk
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1, and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 of Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 59.9 months.
|
Phase 2 Cohort 2: Magrolimab 30 mg/kg + Rituximab
n=14 participants at risk
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 30 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 15.7 months.
|
Phase 2 Cohort 3: Magrolimab 45 mg/kg + Rituximab
n=31 participants at risk
Participants with B-cell iNHL (including FL and MZL) and DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 45 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Participants also received a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each cycle length was 28 days.
The maximum duration of treatment was up to approximately 57.4 months.
|
Phase 2 Cohort 4: Magrolimab 30 mg/kg + Rituximab
n=28 participants at risk
Participants with DLBCL received 1 mg/kg magrolimab IV infusion priming dose (over 3 hours) on Day 1 of Cycle 1, followed by weekly maintenance dose of 30 mg/kg magrolimab IV infusion (over 2 hours) on Days 8, 15, and 22 of Cycle 1; Days 1, 8, 15, and 22 of Cycle 2 and Days 1 and 15 of subsequent cycles in combination with rituximab 375 mg/m\^2 IV infusion on Days 8, 15, and 22 of Cycle 1, followed by 1 dose on Day 1 for Cycles 2 to 6. Thereafter from Cycle 8 and beyond, rituximab was administered on Day 1 of every other cycle (on even cycles). Each Cycle length was 28 days.
The maximum duration of treatment was up to approximately 35.3 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocarditis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Otitis media
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
9.7%
3/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
33.3%
2/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
38.5%
5/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
76.9%
20/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
42.9%
3/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
34.9%
15/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
4/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
32.3%
10/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
39.3%
11/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
33.3%
2/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
4/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
18.6%
8/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
19.4%
6/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
17.9%
5/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Blood and lymphatic system disorders
Red blood cell agglutination
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
33.3%
2/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
3/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
50.0%
13/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
11.6%
5/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
2/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.1%
5/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
10.7%
3/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
9.3%
4/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
9.7%
3/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
66.7%
2/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
3/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
19.4%
6/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Eye disorders
Blindness
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Eye disorders
Iritis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.0%
6/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
11.5%
3/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.3%
7/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
2/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
4/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
38.5%
10/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
18.6%
8/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
29.0%
9/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
21.4%
6/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
50.0%
3/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
61.5%
8/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
57.7%
15/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
71.4%
5/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
27.9%
12/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
19.4%
6/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
25.0%
7/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
4/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Haematochezia
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Haemorrhoids
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
50.0%
3/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
53.8%
7/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
50.0%
13/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
71.4%
5/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
34.9%
15/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
4/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
32.3%
10/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
21.4%
6/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
33.3%
2/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Periodontal disease
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
4/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
33.3%
2/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
38.5%
5/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
26.9%
7/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
42.9%
3/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
27.9%
12/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
25.8%
8/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
4/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Asthenia
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
19.2%
5/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.1%
5/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Catheter site bruise
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Catheter site erythema
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Catheter site pain
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Catheter site pruritus
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Catheter site rash
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Catheter site vesicles
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Chills
|
66.7%
2/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
66.7%
4/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
38.5%
5/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
6/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
34.9%
15/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
42.9%
6/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
22.6%
7/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
17.9%
5/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Facial pain
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
83.3%
5/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
69.2%
9/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
57.1%
4/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
69.2%
18/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
71.4%
5/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
41.9%
18/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
35.7%
5/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
35.5%
11/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
32.1%
9/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Feeling hot
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Infusion site swelling
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
33.3%
2/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Oedema
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
19.2%
5/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
11.6%
5/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
2/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
9.7%
3/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
17.9%
5/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Pain
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
11.6%
5/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
10.7%
3/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Peripheral swelling
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Pyrexia
|
66.7%
2/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
50.0%
3/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
38.5%
5/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
42.9%
3/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
26.9%
7/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
32.6%
14/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
2/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
35.5%
11/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
8/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
General disorders
Temperature intolerance
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
26.9%
7/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
3/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Immune system disorders
Seasonal allergy
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Body tinea
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Cellulitis
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Covid-19
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
4/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Genital candidiasis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Herpes zoster
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Infected bite
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
42.9%
3/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
9.3%
4/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
38.5%
5/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
11.5%
3/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
20.9%
9/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
19.4%
6/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
9.3%
4/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
33.3%
2/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
11.5%
3/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.3%
7/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
12.9%
4/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
4/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
50.0%
3/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
53.8%
7/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
57.1%
4/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
46.2%
12/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
46.5%
20/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
2/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
35.5%
11/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
39.3%
11/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
9.7%
3/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
4/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
4/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Bilirubin conjugated increased
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
17.9%
5/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Body temperature increased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Cd4 lymphocytes decreased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Haptoglobin decreased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Heart rate increased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Immunoglobulins decreased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
33.3%
2/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
30.8%
4/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
4/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
34.6%
9/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.0%
6/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
2/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
21.4%
6/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Total lung capacity decreased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
46.2%
6/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
6/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
57.1%
4/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.3%
10/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
2/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
22.6%
7/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
10.7%
3/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
9.3%
4/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
12.9%
4/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
30.8%
8/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
12.9%
4/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
4/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
19.2%
5/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
10.7%
3/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
4/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
9.7%
3/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
6/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
10.7%
3/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
50.0%
3/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
3/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
11.6%
5/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
4/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
10.7%
3/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
33.3%
2/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
53.8%
7/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
57.1%
4/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.3%
10/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
21.4%
3/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
19.4%
6/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
66.7%
2/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
50.0%
3/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
9.3%
4/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
3/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.0%
6/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
3/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
9.7%
3/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
66.7%
2/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
3/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
19.2%
5/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
2/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
12.9%
4/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
17.9%
5/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Cerebral microangiopathy
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Cranial nerve paralysis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Dizziness
|
66.7%
2/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
33.3%
2/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
6/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
71.4%
5/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
21.4%
3/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.1%
5/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
10.7%
3/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
42.9%
3/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
83.3%
5/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
69.2%
9/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
57.1%
4/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
30.8%
8/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
42.9%
3/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
58.1%
25/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
22.6%
7/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
21.4%
6/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
33.3%
2/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
3/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Restless legs syndrome
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
11.5%
3/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Nervous system disorders
Vibratory sense increased
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Product Issues
Device occlusion
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
3/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
3/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
9.3%
4/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Psychiatric disorders
Procedural anxiety
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
2/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Renal and urinary disorders
Haematuria
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
83.3%
5/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
46.2%
6/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
19.2%
5/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
57.1%
4/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
39.5%
17/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
25.8%
8/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
66.7%
4/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
3/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
30.8%
8/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
57.1%
4/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
30.2%
13/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
21.4%
3/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
32.3%
10/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
8/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
12.9%
4/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
11.5%
3/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
21.4%
3/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
12.9%
4/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
50.0%
3/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
11.5%
3/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal swelling
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
11.6%
5/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
2/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
50.0%
3/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
12.9%
4/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
33.3%
2/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
11.6%
5/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
11.5%
3/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
33.3%
2/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
9.3%
4/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
33.3%
2/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
28.6%
2/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.0%
3/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
42.9%
3/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
18.6%
8/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Purpura senile
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
15.4%
2/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.0%
6/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
33.3%
2/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
9.3%
4/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
2/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.2%
1/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
4.7%
2/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
2.3%
1/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.8%
1/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
6.5%
2/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
16.7%
1/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
3/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
1/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
23.1%
6/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
42.9%
3/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.0%
6/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
14.3%
2/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
12.9%
4/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
17.9%
5/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
1/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
2/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
3.6%
1/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.7%
1/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/3 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/6 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/13 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/26 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/7 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/43 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/14 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
0.00%
0/31 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
7.1%
2/28 • Adverse event: Up to 7.2 years; All-cause mortality: Up to 7.3 years
Adverse Events: The Safety Analysis Set included all enrolled patients who receive at least 1 dose of any study drug. All-cause mortality: The Enrolled Analysis Set included all enrolled patients.
|
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